Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols in compliance with international regulations.
ICON plc
472 Remote Job Openings at ICON plc
The role involves designing and analyzing clinical trials by interpreting complex medical data and maintaining eCRF and data validation specifications. Key duties include managing data reconciliation and communicating study metrics to stakeholders and management.
Lead and coordinate project activities to ensure delivery on time, within budget, and to high quality standards. Focus on managing detailed project plans, resolving issues, and developing team capabilities within a healthcare intelligence context.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
Oncology Scientific Lead, Med Com (Associate Scientific Dir)
ICON plc
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Full Time
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12 hours ago
ICON plc
The Scientific Lead oversees the accuracy and quality of scientific content for assigned projects while mentoring junior medical writing staff. Responsibilities include high-level writing, peer review of deliverables, and collaborating with account managers to ensure timeline adherence.
Acts as the primary operational contact for stakeholders to ensure the timely, cost-efficient, and high-quality delivery of externally sponsored research projects. Manages operational compliance, facilitates governance meetings, and implements corrective action plans for studies not on track.
The Site Contract Manager is responsible for preparing, verifying, and executing invoicing and reporting for an assigned portfolio of accounts. This includes reconciling accounts, investigating discrepancies, and collaborating with the Revenue team to ensure timely billing.
Develop and implement comprehensive strategies to enhance patient recruitment and retention for clinical trials. Collaborate with research teams and healthcare providers to identify target populations and execute outreach via digital and community channels.
The role provides essential support for clinical trials from start-up to close-out, focusing on TMF maintenance and compliance with GCP and SOPs. Key tasks include managing study team shared spaces, tracking metrics, and coordinating logistical support for investigator meetings.
Manage day-to-day operations of early oncology clinical trials to ensure completion according to project goals and regulatory requirements. Lead cross-functional teams and vendors while overseeing trial documentation, budgets, and site engagement.
The specialist is responsible for reviewing and processing cardiac data recordings according to study protocols to ensure high quality and regulatory compliance. They will resolve data discrepancies with sponsors and sites while collaborating with cross-functional teams to meet project timelines.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
Oversee and support the execution of clinical trials to ensure high standards of quality, compliance, and efficiency. Lead clinical coordination tasks, manage site monitoring, and collaborate with cross-functional teams to optimize study processes.
The role involves reviewing medical data for plausibility and consistency while supporting the creation and execution of Medical Data Review Plans. Responsibilities include identifying protocol deviations, managing medical queries, and ensuring data quality standards are met within agreed timelines.
Lead the analysis, interpretation, and management of clinical data across global trials to ensure regulatory compliance and high-quality delivery. Oversee study start-up activities, data cleaning, and database lock processes while partnering with sponsors and cross-functional teams.
Monitor clinical trial sites to ensure adherence to study protocols, regulatory requirements, and GCP standards. Collaborate with cross-functional teams to manage data collection and provide guidance to site staff.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams for accurate data collection.
Provide operational leadership across the full clinical study lifecycle, overseeing study management, site management, and vendor activities. Lead global clinical trials from sourcing strategy through execution and database release to ensure high-quality data delivery.
Lead and oversee end-to-end study start-up activities, including site identification, regulatory submissions, and site activation. Manage a team of professionals while collaborating with sponsors and regulatory teams to ensure compliance and timely trial initiation.
Oversee and manage clinical trial sites across South Africa, Turkey, and Israel to ensure compliance with regulatory requirements and study protocols. Lead site management activities, mentor CRAs, and collaborate with cross-functional teams to ensure successful trial execution.
The role involves coordinating the setup and monitoring of clinical trials, including maintaining study documentation and status reports. It also requires managing stakeholder relationships and ensuring strict compliance with regulatory requirements and patient safety protocols.
Provide technical expertise in CMC strategy for the development, testing, and manufacturing of advanced therapy medicinal products. Manage the preparation of regulatory submission documents and lead communications with government agencies and clients.
Manage end-to-end negotiation of clinical trial agreements and amendments with investigative sites in Greece. Collaborate with cross-functional study teams to ensure timely site activation and maintain audit-ready contractual documentation.
The role involves coordinating the setup and monitoring of clinical trials, ensuring accurate study status reports and documentation. It also requires maintaining strong relationships with investigators and ensuring strict compliance with regulatory requirements and patient safety protocols.
Oversee the planning, execution, and completion of clinical trials while ensuring adherence to budgets, timelines, and regulatory guidelines. Collaborate with cross-functional teams and manage relationships with trial investigators and stakeholders.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Responsibilities include ensuring protocol compliance, maintaining data integrity, and collaborating with investigators to facilitate study conduct.
Develop and implement programming solutions for the analysis and reporting of clinical trial data. Oversee the generation of statistical datasets, tables, listings, and figures for regulatory submissions.
Provide strategic oversight and execution of clinical data management activities across one or more clinical trials. Ensure high standards of data integrity and compliance while coordinating with global cross-functional stakeholders.
The role involves coordinating the setup and monitoring of clinical trials while maintaining accurate study documentation and reports. It also requires managing relationships with clinical investigators and ensuring strict compliance with regulatory requirements and patient safety protocols.
The role involves coordinating project and programme management delivery for clinical trials while acting as the primary contact for sponsors. Key duties include managing 10-15 studies in accordance with Good Clinical Practice and providing regular management reports.
The role involves coordinating and monitoring clinical trials to ensure high-quality outcomes and patient safety. Key tasks include managing study documentation, running sponsor queries, and maintaining relationships with clinical investigators and site staff.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols while maintaining compliance with international regulations.
Manage and oversee local trial operations, including vendor management, IRB coordination, and the execution of local milestones from feasibility to close-out. Collaborate with global and local trial teams to ensure trial excellence and maintain inspection readiness at the country level.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
Lead and coordinate oncology project activities to ensure delivery on time, within budget, and to high quality standards. Responsibilities include managing detailed project plans, leading cross-functional teams, and engaging with stakeholders to align goals.
The specialist is responsible for preparing, verifying, and executing invoicing and reporting for an assigned portfolio of accounts. They must reconcile accounts, investigate discrepancies, and collaborate with stakeholders to ensure timely contract execution.
Oversee the planning and execution of clinical supplies projects to ensure timely delivery and regulatory compliance. Collaborate with cross-functional teams to optimize project timelines, budgets, and resource allocations.
Manage the integration of project team activities and operational strategies for global clinical trials from protocol design to the final study report. Oversee CRO and vendor relationships, including budget oversight, regulatory submissions, and trial-specific documentation.
The role involves coordinating monitoring activities at clinical trial sites to ensure adherence to study protocols and regulatory requirements. It also includes managing project documentation in the Investigator Site File and Trial Master File while mentoring junior staff.
Direct pharmacovigilance and drug safety activities to ensure quality, efficiency, and alignment with business objectives. Lead post-marketing strategies, manage safety monitoring teams, and drive growth through client relationship management and innovation.
The role involves developing and maintaining clinical data collection standards libraries in compliance with CDISC and regulatory requirements. The consultant will act as a subject matter expert to guide implementation, lead departmental initiatives, and provide mentorship to junior staff.
The role involves designing and implementing clinical trial protocols while ensuring adherence to scientific and regulatory standards. Responsibilities include conducting data analysis, collaborating with cross-functional teams, and preparing regulatory submissions and scientific publications.
Support the safety monitoring and reporting of pharmaceutical products by processing adverse event data. Assist in preparing safety reports for regulatory authorities and maintaining pharmacovigilance documentation.
Support the safety monitoring and reporting of pharmaceutical products by processing adverse event data. Assist in preparing safety reports for regulatory authorities and maintaining pharmacovigilance documentation.
Supports operational quality and documentation management for clinical trials, ensuring compliance with regulatory requirements and SOPs. Manages the electronic Trial Master File (eTMF) and coordinates quality metrics and SOP deviations across cross-functional teams.
Support the safety monitoring and reporting of pharmaceutical products by processing adverse event data. Assist in preparing safety reports for regulatory authorities and maintaining pharmacovigilance documentation.
Provide high-level administrative and executive support to clinical operations and project management teams. Responsibilities include organizing meetings, managing study documentation, and supporting financial tasks such as invoice processing and reporting.
The eCOA UAT Lead is responsible for approving system designs and creating comprehensive testing plans and scripts to ensure system readiness before deployment. They proactively identify delivery risks and represent the eCOA Solutions team in meetings with internal teams and sponsors.
Account Manager (Clinical Outcomes Assessments) - Mapi Research Trust
ICON plc
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Full Time
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4 days ago
ICON plc
The Account Manager maintains and expands relationships with COA authors and clients to drive revenue growth and business opportunities. They serve as an expert in COA management, guiding clients on licensing, linguistic validation, and electronic implementation.
Coordinate and monitor clinical trial activities, ensuring accurate study status reports and documentation. Maintain collaborative relationships with stakeholders and investigators while ensuring strict compliance with regulatory requirements and patient safety.
Responsible for ensuring the accuracy, clarity, and quality of scientific documents and publications related to clinical trials. This includes editing regulatory submissions, mentoring junior staff, and ensuring compliance with industry guidelines.
Lead the development and implementation of advanced data science solutions and Data Transfer Specifications (DTS) for clinical trials. Manage external data providers and ensure data structures are consistent, compliant with CDISC standards, and aligned with study timelines.
Lead the development and implementation of advanced data science solutions and Data Transfer Specifications (DTS) for clinical trials. Manage day-to-day clinical data activities, ensuring compliance with CDISC standards and regulatory requirements while overseeing external data vendors.
The Project Manager is responsible for leading and coordinating project activities to ensure delivery on time, within budget, and to high quality standards. Key duties include developing detailed project plans, managing cross-functional teams, and engaging with stakeholders to align goals.
Facilitate the initiation of clinical trials by preparing regulatory documents and coordinating with stakeholders for necessary approvals. Maintain accurate records of submissions and support the development of study protocols and informed consent forms.
Lead the production, formatting, and layout of complex scientific posters and clinical trial deliverables for medical congresses. Serve as a subject matter expert to drive process improvements and ensure high-quality, compliant print-ready files.
Identify and build relationships with study investigators and sites to conduct feasibility and potential study participation. Develop recruitment strategies and maintain accurate data within the investigator database and feasibility management systems.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Monitor trial sites, conduct performance assessments, and collaborate with cross-functional teams to ensure data integrity and participant safety.
The role is responsible for driving the adoption of RBQM practices and overseeing quality risk surveillance across assigned clinical trials. This includes facilitating risk assessments, monitoring quality tolerance limits, and leading risk review meetings to implement mitigation strategies.
Support the design, implementation, and management of clinical trials by coordinating site initiation and patient recruitment. Ensure adherence to protocols and regulatory guidelines while collaborating with cross-functional teams for data accuracy.
Coordinate site activations and maintenance tasks across multiple clinical studies while acting as the primary site liaison. Ensure the accuracy of Critical Document Packages and maintain high-quality documentation within the Trial Master File.
Lead the EU Audit Defense Team in managing client audits for clinical, PV, and technology services globally. Coordinate quality assurance strategies, resolve compliance issues, and oversee the closure of audit observations and CAPAs.
Assist in organizing and maintaining tracking systems, study files, and training materials from clinical study start-up to closeout. Support the Study Management team through quality checks, TMF archiving, and coordination of study-related communications.
The role involves coordinating the setup and monitoring of clinical trials while maintaining accurate study documentation and status reports. You will collaborate with stakeholders and clinical investigators to ensure patient safety and regulatory compliance.
Coordinate the administrative and financial management of COA licensing projects, focusing on revenue recognition and budget tracking. Maintain project trackers and liaise with internal and external stakeholders to ensure timely deliverables.
Oversee the negotiation and management of clinical trial agreements and budgets for complex global studies. Lead the finalization of site contracts while mentoring contract specialists and collaborating with legal and finance stakeholders.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
Oversee toxicology and safety studies conducted at CROs, supporting all aspects of study design, execution, and reporting. Act as the primary communication point between internal experts and external partners to deliver high-quality regulatory studies.
Independently manage the negotiation and execution of clinical trial agreements and budgets for various studies. Collaborate with internal stakeholders and investigator sites to ensure compliant and efficient study start-up.
The Site Specialist II independently manages site support activities and acts as the primary operational contact for clinical sites. Key duties include coordinating document collection, maintaining site metrics, and supporting logistics for investigator meetings and monitoring visits.
The role focuses on building and maintaining strong relationships with clinical trial site stakeholders to enhance engagement and performance. Responsibilities include providing guidance on study protocols and collaborating with internal teams to implement tailored engagement strategies.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and provide guidance to site staff and other CRAs.
Facilitate the initiation of clinical trials by preparing regulatory documents and coordinating with stakeholders for necessary approvals. Maintain accurate records of submissions and support the development of study protocols and informed consent forms.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
The Clinical Trial Manager is responsible for creating and maintaining clinical project documents while ensuring compliance with regulatory and customer requirements. They lead a team of clinical operations colleagues and serve as the primary liaison for clients and vendors to ensure successful project delivery.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. It also requires ensuring protocol compliance, data integrity, and collaborating with investigators to maintain high-quality clinical data.
The role involves coordinating the setup and monitoring of clinical trials, ensuring accurate study status reports and documentation. It also requires maintaining collaborative relationships with investigators and ensuring strict compliance with regulatory requirements and patient safety.
Support the management of clinical trial sites by assisting with monitoring activities and ensuring compliance with study protocols. Maintain operational efficiency through documentation preparation, data entry, and collaboration with cross-functional teams.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols in compliance with international regulations.
Lead the development of clinical study documents and regulatory submissions while collaborating with cross-functional teams to analyze trial data. Provide strategic input for clinical development programs and mentor junior medical writers to ensure high-quality scientific output.
The role involves reviewing and negotiating contracts and legal documents related to clinical trials and vendor relationships. It also requires collaborating with cross-functional teams to mitigate risks and maintaining accurate contract records.
The Principal Clinical Data Science Lead serves as the primary contact for end-to-end data review activities on clinical trials. They are accountable for delivering high-quality clinical data science deliverables on time and within financial metrics.
Perform comprehensive site management and monitoring activities for oncology clinical trials to ensure data integrity and subject safety. Act as the primary liaison between the client's trial team and sites while maintaining inspection readiness and compliance with protocols.
Manage and oversee local trial milestones, vendors, and resourcing from feasibility through study close-out. Collaborate with global trial leaders and local site managers to ensure trial excellence and inspection readiness.
Manage the full grant application process, from identifying opportunities to developing compelling proposals. Ensure compliance with funding requirements and track outcomes to support clinical programmes.
Oversee and coordinate centralized review activities for clinical trials, including imaging and laboratory analyses. Lead the planning and execution of workstreams to ensure deliverables meet quality and timeline expectations.
Support project managers in planning, executing, and monitoring clinical trials while coordinating study activities and data collection. Collaborate with cross-functional teams to develop study protocols and ensure project milestones are achieved.
The role involves conducting risk assessments on clinical trial data to identify potential issues and recommend mitigation strategies. You will collaborate with cross-functional teams to implement risk management plans and monitor data quality throughout the trial process.
Lead and manage regional clinical operations projects to ensure successful execution and delivery of objectives. Responsibilities include developing project plans, leading cross-functional teams, and mentoring staff to maintain quality outcomes.
Provide medical and therapeutic expertise to guide project teams and ensure clinical studies adhere to ethical and legal standards. Interact with sponsors and investigative sites to manage protocol issues and support business development efforts.
Oversee the management and analysis of clinical trial data to ensure accuracy, integrity, and regulatory compliance. Lead data teams in designing strategies and optimizing workflows to support clinical research objectives.
Lead a team of statistical analysts and programmers to design and conduct analyses for peri and post-approval studies. Collaborate with cross-functional teams to develop statistical analysis plans and oversee the validation of statistical models.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
The Digital Media Buyer is responsible for deploying, optimizing, and reporting on digital advertising campaigns to drive patient recruitment for clinical studies. They collaborate with design and copy teams to create impactful web content and liaise with external vendors and study leads.
Facilitate the initiation of clinical trials by preparing regulatory documents and coordinating with stakeholders for necessary approvals. Maintain accurate records of submissions and support the development of study protocols and informed consent forms.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and GCP standards. Conduct site visits to assess performance, resolve issues, and collaborate with cross-functional teams for accurate data reporting.
Manage inspection readiness and audit preparation activities for site contracting to ensure quality and compliance. Perform quality reviews of site contracts and maintain process documentation and tracking databases.
Lead the end-to-end planning and implementation of IRT/RTSM systems to support clinical trials, including randomization and supply management. Coordinate integrations between IRT and other clinical systems while ensuring regulatory compliance and seamless data flow.
The coordinator supports project managers in the planning, execution, and monitoring of clinical trials. Key duties include managing study documentation, coordinating cross-functional teams, and implementing process improvements for operational efficiency.
Lead and execute complex scientific clinical data review activities at both trial and program levels to ensure high-quality, inspection-ready data. Collaborate with physicians and scientists to drive data review strategies and ensure compliance with regulatory requirements.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams for accurate data collection.
Act as a strategic liaison between ICON and key investigator sites to strengthen relationships and support study performance. You will manage site needs, facilitate communication across multiple studies, and monitor performance metrics to drive improvements.
Responsible for the timely preparation and submission of comprehensive safety reports, including PSURs and ICSRs. The role involves conducting data analysis to assess pharmaceutical safety profiles and collaborating with cross-functional teams.
Support the safety monitoring and reporting of pharmaceutical products by processing adverse event data. Assist in preparing safety reports for regulatory authorities and maintaining pharmacovigilance documentation.
Facilitate the initiation of clinical trials by preparing regulatory documents and coordinating approvals with internal and external stakeholders. Maintain accurate records of submissions and support the development of study protocols and informed consent forms.
The role involves overseeing vendors and CROs to ensure adherence to budgets, timelines, and organizational objectives for clinical protocols. Key duties include managing site readiness, reviewing monitoring reports, and ensuring TMF compliance with regulations.
Responsible for editing and proofreading scientific documents, including clinical study reports and regulatory submissions, to ensure accuracy and quality. The role also involves mentoring junior editors and collaborating with medical writers to improve content clarity.
Lead the procurement, distribution, and inventory management of clinical supplies to support the execution of clinical trials. Collaborate with cross-functional teams and vendors to ensure quality delivery and alignment with regulatory requirements.
Lead the implementation and optimization of clinical systems and technologies to ensure efficient trial execution. Manage third-party IRT vendors and oversee the creation and execution of UAT test plans and documentation.
Develop and maintain programming solutions for CDMS, data validation, and custom reports to support clinical trial data analysis. Collaborate with cross-functional teams and mentor junior programmers to ensure data accuracy and operational efficiency.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and GCP standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams for accurate data collection.
The CRA is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams for accurate data collection.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols while maintaining regulatory and ethical compliance.
Oversee and manage clinical trial activities to ensure adherence to study protocols, regulatory requirements, and GCP standards. Monitor trial sites, conduct performance assessments, and collaborate with cross-functional teams to ensure accurate data collection.
Oversee clinical trial management workstreams, ensuring deliverables meet quality and timeline expectations. This includes designing protocols, managing day-to-day operations, and analyzing clinical data to optimize study outcomes.
Oversee and manage clinical trial sites to ensure compliance with regulatory requirements, study protocols, and company standards. Lead site management activities and mentor CRAs to develop team capability and ensure data integrity.
Manage the end-to-end grant application process, including identifying opportunities and developing compelling proposals. Ensure compliance with funding requirements and track outcomes to support clinical programmes.
Govern and orchestrate all releases across the multi-agent framework, agent services, and central AI platform. Ensure all production deployments are secure, compliant, stable, and scalable while managing the end-to-end release lifecycle.
The Medical Director oversees the execution of clinical trials in neuroimmunology, serving as the medical lead for assigned projects. Responsibilities include developing clinical development plans, overseeing medical writing for regulatory documents, and managing clinical teams.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams for accurate data collection.
The Global Study Manager is responsible for designing, implementing, and managing the day-to-day operations of global clinical trials. This includes collaborating with cross-functional teams to develop protocols and analyzing clinical data to optimize study outcomes.
The Clinical Trial Liaison provides scientific and clinical support to investigators to ensure study design understanding and goal achievement. They also develop and optimize recruitment strategies to drive successful patient enrollment across study sites.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. It also requires ensuring protocol compliance, data integrity, and collaborating with investigators to maintain high-quality clinical data.
Strategize and oversee patient recruitment initiatives for clinical trials to enhance patient access and engagement. Lead cross-functional teams and build partnerships with healthcare providers and advocacy groups to optimize recruitment and retention.
Manage clinical trial operations activities, including budget oversight, study start-up, and enrollment. Coordinate delivery, resolve issues, and mentor Clinical Research Associates to ensure high-quality outcomes.
The role involves designing statistical methodologies and analysis plans for clinical trials while developing and validating models to evaluate treatment outcomes. The analyst will collaborate with cross-functional teams to interpret complex medical data and support regulatory submissions.
Lead the initiation of clinical trials by preparing and submitting regulatory documents and coordinating with stakeholders for study approvals. Manage accurate records of submissions and provide guidance to study teams on regulatory best practices.
The role involves coordinating the setup and monitoring of clinical trials, including maintaining study documentation and status reports. It also requires managing stakeholder relationships and ensuring compliance with regulatory requirements to protect patient safety.
Independently manage the negotiation and execution of clinical trial agreements and budgets for various studies. Collaborate with internal stakeholders and investigator sites to ensure compliant and efficient study start-up.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols in compliance with international regulations.
Facilitate the development of proposals, budgets, and costing tools for clinical trials to support business development. Maintain operational effectiveness of costing systems and provide training and support to users.
Design, develop, and validate SAS programs for the analysis and reporting of clinical trial data. Collaborate with biostatisticians to create analysis plans and mentor junior programmers on best practices.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols and maintain regulatory compliance.
Oversee regulatory affairs delivery and provide strategic expertise in drug development across multiple therapeutic areas. Act as a trusted advisor to clients and represent the department in business development activities to generate new opportunities.
Manage quality assurance and compliance activities for clinical trials to ensure adherence to regulatory standards. Develop QA strategies, conduct audits, and lead cross-functional teams to resolve quality issues and implement corrective actions.
Lead and manage oncology clinical trial projects to ensure successful execution and delivery of objectives. Responsibilities include developing project plans, leading cross-functional teams, and mentoring staff to foster a culture of excellence.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
The Agreement Specialist is responsible for reviewing, analyzing, and negotiating clinical trial agreements and vendor contracts to ensure regulatory compliance. They collaborate with cross-functional teams to mitigate contract risks and maintain accurate records within contract management systems.
Oversee all imaging aspects for MASH clinical trials and provide scientific expertise to commercial and operations teams. Support business growth by promoting medical imaging services to clients and contributing to proprietary software requirements.
Serve as the primary contact between investigational sites and sponsors while conducting all types of site visits. Ensure site compliance with ICH-GCP and Health Canada regulations while managing data quality and patient safety reporting.
The role involves managing invoicing, account reconciliation, and contract progression for a portfolio of accounts. It also requires negotiating clinical trial agreements and budgets with sites while collaborating with internal study startup and revenue teams.
Oversee the end-to-end process of activating clinical trial sites, ensuring efficiency and regulatory compliance. Lead and mentor a team of Site Activation Leads while collaborating with cross-functional teams to meet study timelines.
Clinical Research Associate II or Senior Clinical Research Associate
ICON plc
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Full Time
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11 days ago
ICON plc
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Responsibilities include ensuring protocol compliance, maintaining data integrity, and collaborating with investigators to facilitate study conduct.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
The role involves managing the end-to-end grant application process, including identifying opportunities and developing compelling proposals. The specialist is also responsible for ensuring compliance with funding requirements and reporting on grant outcomes.
The role involves coordinating the setup and monitoring of clinical trials, ensuring accurate study status reports and documentation. It also requires maintaining strong relationships with investigators and ensuring patient safety through strict regulatory compliance.
Coordinate and monitor clinical trial activities, ensuring accurate study status reports and documentation. Maintain collaborative relationships with investigators and site staff while ensuring strict compliance with regulatory requirements and patient safety.
Manage the full spectrum of investigator engagement and site-level strategy to ensure predictable enrollment and high-quality data delivery. Act as a scientific ambassador to align investigators with protocol intent and optimize trial conduct across priority sites.
Manage the full spectrum of investigator engagement and site-level strategy to ensure predictable enrollment and high-quality data delivery. Act as a scientific ambassador to align investigators with protocol intent and optimize trial conduct through strategic relationship management.
Manage the full spectrum of investigator engagement and site-level strategy to ensure predictable enrollment and high-quality data delivery. Act as a scientific ambassador to align investigators with protocol intent and optimize clinical trial conduct.
Serve as the primary contact between investigational sites and sponsors while conducting various site visits including selection, initiation, and close-out. Ensure site compliance with ICH-GCP and regulations while managing data quality and patient safety reporting.
Serve as the primary contact between investigational sites and sponsors while conducting various site visits to ensure compliance with ICH-GCP and SOPs. Responsibilities include monitoring patient safety, overseeing drug accountability, and driving high-quality data entry.
Conduct site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. Collaborate with investigators to maintain high-quality clinical data and prepare essential study documentation.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols in compliance with international regulations.
Provide strategic leadership in the design and implementation of eCOA clinical systems and technologies for a pharmaceutical sponsor. Manage eCOA vendors, lead study-specific technology deployment, and ensure deliverables meet quality, cost, and timeline expectations.
Develop and deploy user-facing support materials and training to drive the adoption of clinical business systems. Collaborate with stakeholders and product managers to align system capabilities with business priorities and resolve end-user challenges.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols in compliance with international regulations.
Lead feasibility strategy and execution at the study level to optimize clinical trial delivery and enrollment for rare disease programs. Analyze complex operational data to provide strategic recommendations and risk assessments to cross-functional study teams.
Lead the end-to-end study start-up strategy and execution for assigned clinical trials. Manage site activation timelines, regulatory requirements, and stakeholder partnerships to ensure efficient study launch.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
The role involves coordinating and administering clinical trials while ensuring compliance with regulatory requirements and protocols. Key duties include maintaining study documentation and collaborating with cross-functional teams to facilitate smooth trial execution.
Lead the development of high-quality regulatory and clinical documents, including clinical study reports and protocols. Oversee medical writing workstreams and mentor junior writers to ensure adherence to industry standards and timelines.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
Lead the design, development, and implementation of advanced clinical systems aligned with study protocols and operational needs. Collaborate with cross-functional teams to drive system enhancements and provide strategic guidance on new technology implementation.
Lead the design, development, and implementation of advanced clinical systems to enhance trial execution and align with study protocols. Collaborate with cross-functional teams to drive system innovations and provide strategic guidance on new technology adoption.
Lead the initiation of clinical trials by preparing and submitting regulatory documents and coordinating with stakeholders for study approvals. Manage accurate records of submissions and provide guidance to study teams on regulatory best practices.
The role involves reviewing, analyzing, and negotiating contracts and legal documents related to clinical trials and vendor relationships. It also requires collaborating with cross-functional teams to mitigate contract risks and maintaining accurate records in contract management systems.
Manage clinical trial operations activities, including budget oversight and the development of monitoring plans. Coordinate study start-up, drive enrollment, and mentor Clinical Research Associates to ensure high-quality outcomes.
Serve as the primary contact between investigational sites and sponsors while conducting various site visits to ensure compliance with ICH-GCP and SOPs. Responsibilities include monitoring patient safety, overseeing drug accountability, and managing data quality and site documentation.
Lead and coordinate country-level clinical study activities from startup through close, ensuring delivery on time, within budget, and to quality standards. Oversee pCROs and local study teams while managing risk, site activation, and regulatory compliance.
The associate will monitor pharmaceutical product safety by collecting, analyzing, and reporting adverse event information. Key duties include conducting signal detection, risk assessments, and preparing regulatory safety submissions.
Lead the collection, evaluation, and processing of adverse event reports while ensuring regulatory compliance. Manage the submission of periodic safety update reports and oversee the integrity of pharmacovigilance databases.
Lead the preparation of complex client-focused proposals, budgets, and grids for new business opportunities. Coordinate with operational departments and stakeholders to ensure proposals meet business needs and are submitted on time.
Develop and maintain costing tools and systems to support Business Development in winning new business. Provide training and support to users while ensuring the delivery of high-quality client proposals and budgets.
The role involves leading the preparation of complex client-focused proposals, budgets, and grids for new business opportunities within the Early Phase group. It requires coordinating with operational departments and sales teams to ensure strategies meet business needs and are submitted on time.
Lead and oversee pharmacovigilance activities across clinical trials and post-marketing studies, ensuring adherence to regulatory requirements. Coordinate cross-functional teams to manage project planning, execution, and the accurate reporting of adverse events.
Leads the preparation of study documents and manages interactions with internal functions and external service providers to ensure efficient study delivery. Oversees CRO project managers, manages budgets, and ensures compliance with ICH/GCP guidelines to keep studies inspection-ready.
The role involves negotiating clinical trial agreements, budgets, and payment terms with assigned sites. It also requires managing invoicing, reporting, and collaborating with internal teams to improve site budgeting and contracting metrics.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols and maintain regulatory compliance.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Responsibilities include ensuring protocol compliance, data integrity, and collaborating with investigators to maintain high-quality clinical data.
Lead site start-up and activation tasks, including feasibility assessments, contract negotiations, and regulatory submissions. Ensure patient welfare by reviewing informed consent forms and maintaining high quality and compliance standards.
The role involves preparing, verifying, and executing invoicing and reporting for an assigned portfolio of accounts. It also requires reconciling accounts, investigating discrepancies, and collaborating with the Revenue team to ensure timely billing.
Oversee the planning and execution of clinical supplies projects to ensure timely delivery and regulatory compliance. Collaborate with cross-functional teams to optimize budgets, timelines, and logistics for clinical trial supply management.
Lead and manage complex projects and programs across various departments to ensure delivery on time, within scope, and within budget. Oversee site resourcing and workforce planning while coordinating cross-functional teams to align with strategic business objectives.
Manage the end-to-end grant application process, including identifying opportunities and developing compelling proposals. Ensure compliance with funding requirements and track grant activities and outcomes.
Oversee regulatory affairs operations and develop global regulatory strategies for clinical trials. Lead interactions with regulatory agencies and ensure compliance with industry trends and requirements.
Design, develop, and test software applications to support clinical trial operations and data management. Collaborate with cross-functional teams to gather requirements and ensure high-quality software delivery through clean code and best practices.
The consultant supports operational staff in using ADaM and define.xml within Medidata standards and develops tools to improve deliverable quality. They also lead sponsor standards teams, manage metadata repositories, and mentor other consultants.
Lead teams in delivering high-quality feasibility assessments and efficient site activation for global clinical trials. Coordinate start-up strategies, manage essential documentation, and monitor performance metrics to drive operational excellence.
Responsible for clinical out-of-pocket cost forecasting, budget creation, and management from concept through closeout. This includes providing financial leadership, managing quarterly closes, and developing trial budget estimates for leadership review.
The Safety Scientist is responsible for conducting safety surveillance and interpreting complex medical data for clinical trials. They collaborate with cross-functional teams to develop safety management plans and prepare documentation for regulatory submissions.
The role provides operational expertise in clinical supply areas including storage, inventory, and cold chain distribution. It ensures the quality and compliance of processes used to supply Clinical Trial Material (CTM) while collaborating with cross-functional teams.
Accountable for site selection and study start-up activities for Phase I-IV trials, ensuring timelines and deliverables are met. Manages regulatory submissions, site documentation, and financial contracts to achieve site greenlight.
Manage the lifecycle of clinical contracts and NDAs, serving as the primary liaison between Clinical Operations and Legal. Responsible for negotiating site budgets, processing contract requests, and ensuring timely invoicing and account reconciliation.
Oversee and manage clinical trial sites to ensure compliance with regulatory requirements, study protocols, and company standards. Lead site management activities and mentor CRAs to develop team capability and ensure data integrity.
Lead and coordinate global project activities to ensure delivery on time, within budget, and to high quality standards. Responsibilities include managing detailed project plans, leading cross-functional teams, and engaging with stakeholders to align with organizational goals.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. It also requires ensuring protocol compliance, data integrity, and collaborating with investigators to maintain high-quality clinical data.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
The role focuses on coordinating clinical trial management delivery, overseeing budgets, and ensuring effective study oversight. Key duties include mentoring CRAs, driving study start-up and enrollment, and fostering relationships with sponsors and vendors.
Lead the development and management of Data Transfer Specifications (DTS) to align external data providers with required structures. Oversee data standardization according to CDISC standards and manage operational oversight of external data vendors.
Facilitate the initiation of clinical trials by preparing regulatory documents and coordinating with stakeholders for necessary approvals. Maintain accurate records of submissions and support the development of study protocols and informed consent forms.
The role focuses on coordinating clinical trial management delivery, overseeing budgets, and ensuring effective study oversight. Key duties include mentoring CRAs, driving enrollment, and fostering relationships with sponsors and vendors.
Responsible for the tactical and strategic direction of imaging projects and the management of a project management team. Accountable for ensuring project consistency with corporate strategy, compliance with policies, and optimal resource allocation.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and provide guidance to site staff and other CRAs to maintain high quality standards.
Lead the end-to-end design, delivery, and support of Randomization and Trial Supply Management (RTSM) and eCOA systems. Act as the primary subject matter expert collaborating with clinical operations and vendors to ensure system quality and regulatory compliance.
Oversee the execution of clinical trials to ensure they are conducted efficiently, on time, and in compliance with regulatory requirements. Lead operational planning, monitor performance metrics, and mentor junior staff to enhance team capability.
Manage and negotiate contractual agreements for clinical research projects while ensuring alignment with regulatory requirements and company policies. Provide guidance to project teams on contract interpretation and maintain organized records of milestones and deliverables.
Lead the design and development of advanced clinical systems and eCRF specifications to align with study protocols. Manage the implementation of edit checks, database changes, and quality control reviews to ensure efficient trial execution.
The role involves leading the collection and processing of adverse event reports and conducting safety data analysis to identify potential signals. Additionally, the associate is responsible for preparing periodic safety update reports (PSURs) and ensuring compliance with international regulatory guidelines.
The associate will monitor pharmaceutical product safety by collecting, analyzing, and reporting adverse event information. Key duties include conducting signal detection, risk assessments, and preparing regulatory safety submissions.
Lead and coordinate project activities to ensure delivery on time, within budget, and to high quality standards. Oversee project execution including planning, resource management, and stakeholder engagement.
Lead the initiation of clinical trials by coordinating essential document management and ensuring regulatory compliance for site activation. Manage communication between study teams and investigator sites to ensure timelines are met according to GCP and Sponsor standards.
Lead the development of high-quality regulatory and clinical documents, including clinical study reports and protocols. Oversee medical writing workstreams and mentor junior writers to ensure adherence to industry standards and timelines.
The role involves reviewing and negotiating contracts and legal documents related to clinical trials and vendor relationships. It also requires collaborating with cross-functional teams to mitigate risks and maintaining accurate contract records.
Direct scientific operations and clinical research support for Oncology/Solid Tumors, focusing on protocol development and study start-up. Responsibilities include drafting regulatory documents like INDs and Investigator's Brochures while leading clinical matrix teams.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
The CRA is responsible for conducting site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. They will collaborate with investigators and perform data reviews to maintain high-quality clinical data.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and GCP standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams for accurate data reporting.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. It also requires ensuring protocol compliance, data integrity, and collaborating with investigators to maintain high-quality clinical data.
Lead medical affairs delivery and provide strategic medical leadership for project teams within the Endocrinology and Obesity portfolio. Ensure compliance with ethical and regulatory standards while offering expert scientific guidance throughout project lifecycles.
Lead and manage clinical projects to ensure successful execution and delivery of objectives within the Internal Medicine team. This includes developing project plans, leading cross-functional teams, and collaborating with stakeholders to define project scope.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance and data integrity while collaborating with investigators to maintain high-quality clinical data.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. It also requires ensuring protocol compliance, data integrity, and collaborating with investigators to maintain high-quality clinical data.
Oversee and manage Phase II–IV clinical trials to ensure compliance with protocols, regulatory requirements, and industry standards. Conduct site visits and collaborate with cross-functional teams to ensure data integrity and patient safety.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
Lead and manage clinical trial projects to ensure successful execution and delivery of objectives. Responsibilities include developing project plans, leading cross-functional teams, and mentoring staff to foster a culture of excellence.
The Site Specialist II manages site support activities, acting as the primary operational contact to ensure efficient study start-up and maintenance. Key duties include coordinating site documentation, maintaining trial metrics, and providing guidance to junior colleagues.
Lead the strategy and oversight for identifying and recommending investigator sites for assigned clinical studies. Balance data-driven analysis with operational insights to ensure efficient trial delivery and validate selection assumptions.
Lead feasibility strategy and execution for clinical studies, translating complex enrollment data into actionable recommendations for study planning. Collaborate cross-functionally to optimize trial delivery and mentor junior team members on analytical best practices.
Responsible for completing country and regional clinical trial regulatory deliverables while ensuring compliance with ICH-GCP and scientific principles. The role involves managing submission documentation, coordinating reviews, and providing strategic input for regulatory authority submissions.
The role involves coordinating the setup and monitoring of clinical trials, ensuring accurate study status reports and documentation. It also requires maintaining strong relationships with investigators and ensuring patient safety through strict regulatory compliance.
The Clinical Data Science Lead serves as the primary contact for data review activities to ensure data is fit for analysis. Responsibilities include overseeing study lifecycles, managing timelines, forecasting budgets, and collaborating with cross-functional global groups.
Lead and manage clinical trial projects to ensure successful execution and delivery of objectives. Responsibilities include developing project plans, leading cross-functional teams, and mentoring staff to maintain quality outcomes.
Lead the preparation and submission of regulatory documents and clinical trial applications to ensure compliance. Coordinate with internal and external stakeholders to obtain necessary authorizations for study initiation.
Implement an annual sales plan to achieve territory quotas and prospect new RFP leads. Collaborate cross-functionally to assemble expert teams for bid defenses and track all client interactions in Salesforce.
The role involves coordinating and monitoring clinical trial activities to ensure high-quality outcomes and patient safety. Key tasks include managing study documentation, running sponsor queries, and maintaining relationships with clinical investigators and site staff.
Independently monitor Phase II-IV clinical trials to ensure compliance with ICH-GCP and regulatory requirements. Manage site visits, study documentation, and collaborate with cross-functional teams to ensure patient safety and data quality.
Independently monitor Phase II–IV clinical trials to ensure compliance with ICH-GCP and regulatory requirements. Manage site qualification, initiation, and close-out visits while ensuring data integrity and patient safety.
Independently monitor Phase II–IV clinical trials to ensure compliance with ICH-GCP and regulatory requirements. Manage site visits, study documentation, and collaborate with cross-functional teams to ensure patient safety and data quality.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. It also requires ensuring protocol compliance, data integrity, and collaborating with investigators to maintain high-quality clinical data.
Independently monitor Phase II–IV clinical trials to ensure compliance with ICH-GCP and regulatory requirements across multiple therapeutic areas. Manage site visits, ensure data integrity, and collaborate with investigators to facilitate smooth study conduct.
Conduct remote review and analysis of clinical trial data to identify risks to patient safety and data quality. Collaborate with site personnel to implement corrective actions and optimize centralized monitoring strategies.
Manage and independently monitor Phase I-III clinical trials for biotech sponsors in the Netherlands to ensure regulatory compliance. Conduct site visits and manage study documentation, regulatory submissions, and ethics approvals while collaborating with cross-functional teams.
Manage and independently monitor Phase II–IV clinical trials for biotech sponsors in the Netherlands to ensure regulatory compliance. Coordinate site visits, manage study documentation, and collaborate with cross-functional teams to ensure patient safety and data quality.
Support the safety monitoring and reporting of pharmaceutical products by processing adverse event data. Assist in preparing safety reports for regulatory authorities and maintaining pharmacovigilance documentation.
Lead business development strategy for real-world data and evidence generation solutions to expand market presence and revenue. Manage the end-to-end sales process and foster high-value strategic partnerships with life sciences and healthcare organizations.
Manage data management teams and programs for early phase clinical trials, ensuring delivery within budget and timelines. Coordinate with cross-functional teams to maintain data integrity and ensure compliance with regulatory guidelines.
The role involves coordinating the setup and monitoring of clinical trials, ensuring accurate study status reports and documentation. It also requires maintaining strong relationships with investigators and ensuring compliance with regulatory requirements and patient safety.
The analyst is responsible for the setup and implementation of Central Monitoring across a portfolio of clinical studies. This includes creating Central Monitoring Plans, identifying site performance issues, and leading Quality Risk Review Meetings.
The role involves collecting and reviewing adverse event reports to ensure timely regulatory reporting. Additionally, the associate conducts signal detection and risk assessments to identify potential safety issues for pharmaceutical products.
Oversee regulatory affairs delivery and provide strategic expertise in drug development across the ICON portfolio. Act as a trusted advisor to clients and represent the department in business development activities to generate new opportunities.
Lead the design and development of clinical systems and eCRF specifications to align with study protocols. Manage system requirements, perform quality control reviews, and drive post-production database changes.
The Medical Data Reviewer coordinates the medical data review process and ensures data consistency and plausibility across studies. They draft Medical Data Review Plans and manage medical queries in collaboration with the Medical Director and Biometrics team.
Support the safety monitoring and reporting of pharmaceutical products by processing adverse event data. Assist in preparing safety reports for regulatory authorities and maintaining pharmacovigilance documentation.
The role involves drafting, reviewing, and negotiating contracts with clients, vendors, and partners to ensure business objectives and legal standards are met. It also includes managing the full contract lifecycle from initiation through execution and renewal.
Lead the preparation and review of clinical study documents, including protocols, CSRs, and regulatory submissions. Collaborate with cross-functional teams to analyze clinical trial data and mentor junior medical writers to ensure high-quality scientific output.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
Develop, validate, and maintain complex statistical programs for data manipulation and reporting in clinical trials. Collaborate with biostatisticians to implement statistical analysis plans and mentor junior programmers on best practices.
Lead the development, review, and optimization of global and local informed consent forms for complex clinical trials. Advise study teams on strategy and interface with sponsors and regulatory bodies to ensure compliance.
Develop and manage timelines, budgets, and regulatory compliance for post-trial access (PTA) programs for investigational products. Lead cross-functional teams to ensure uninterrupted patient access and maintain inspection readiness through accurate documentation.
Lead and coordinate project activities to ensure delivery on time, within budget, and to high quality standards. Focus on managing detailed project plans, resolving issues, and developing team capabilities through cross-functional leadership.
Lead and manage projects to ensure the successful execution and delivery of project objectives within a clinical research environment. Responsibilities include developing project plans, leading cross-functional teams, and mentoring staff to foster a culture of excellence.
Responsible for preparing and editing informed consent documents using health-literate language to help clinical trial candidates make informed decisions. This includes collaborating with protocol authors and managing the design and planning of documentation across multiple therapeutic areas.
Responsible for developing drug supply planning strategies and managing overall supplies for clinical studies. This includes managing forecasting, IRT system set-up, and coordinating delivery timelines across internal and external stakeholders.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
Oversee the end-to-end contract management process, including drafting, reviewing, and negotiating agreements with clients and vendors. Collaborate with legal and finance departments to ensure compliance with regulatory requirements and monitor contract performance throughout the project lifecycle.
Lead the preparation, submission, and maintenance of CTAs and IND applications to ensure compliance with local and global regulatory requirements. Oversee regulatory workstreams and provide strategic input to clinical study teams to align trial design with regional expectations.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
Coordinate the setup and monitoring of oncology clinical trials while maintaining accurate study documentation and reports. Build collaborative relationships with investigators and site staff to ensure patient safety and regulatory compliance.
The role involves designing and analyzing clinical trials and interpreting complex medical data to advance innovative treatments. The liaison is responsible for cultivating relationships and recruiting appropriate sites to participate in trials.
Facilitate the initiation of clinical trials by preparing regulatory documents and coordinating with stakeholders for necessary approvals. Maintain accurate records of submissions and support the development of study protocols and informed consent forms.
Lead the design, analysis, and reporting of complex clinical trials within the Biosimilars group. Oversee the work of supporting statisticians and provide strategic statistical input for regulatory and scientific requirements.
Lead and coordinate project activities for post-trial access programs to ensure delivery on time, within budget, and to quality standards. This includes managing timelines, budgets, and cross-functional teams to facilitate uninterrupted patient access to investigational products.
Acts as the primary point of communication for clinical sites to streamline operations and ensure trial compliance throughout the lifecycle. Manages site selection, recruitment targets, budget forecasting, and ensures high standards of data quality and inspection readiness.
Lead the end-to-end design, execution, and reporting of global oncology clinical trials. Accountable for delivering studies to time, quality, and budget while managing vendors and cross-functional matrix teams.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance and data integrity while collaborating with investigators to maintain high-quality clinical data.
The CRA is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
Oversee the implementation and management of Interactive Response Technology (IRT) solutions for clinical trials. This includes managing project plans, budgets, and timelines while collaborating with cross-functional teams to ensure regulatory compliance.
Lead and manage global clinical trial projects to ensure successful execution and delivery of objectives. Responsibilities include developing project plans, managing cross-functional teams, and mentoring staff to foster a culture of excellence.
The role involves processing investigator payments accurately and timely according to study protocols while maintaining compliant documentation. It also requires resolving payment discrepancies with internal teams and assisting in the preparation of financial reports.
Serve as the primary contact between investigation sites and sponsors while conducting various site visits to ensure compliance with ICH-GCP and SOPs. Responsibilities include monitoring patient safety, overseeing drug accountability, and managing data quality and site documentation.
Serve as the primary contact between investigation sites and sponsors while conducting various site visits to ensure compliance with ICH-GCP and SOPs. Responsibilities include monitoring patient safety, overseeing drug accountability, and managing data quality and site documentation.
Serve as the primary contact between investigational sites and sponsors while conducting various site visits to ensure compliance with regulations. Responsibilities include monitoring patient safety, overseeing drug accountability, and managing data quality and site documentation.
Coordinate and execute centralized review activities for clinical trials, including imaging and laboratory assessments. Monitor process quality and maintain comprehensive documentation to ensure adherence to protocol and regulatory standards.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and GCP standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and GCP standards. Conduct site visits to assess performance, resolve issues, and collaborate with cross-functional teams for accurate data reporting.
The role involves coordinating the setup and monitoring of clinical trials, ensuring accurate study status reports and documentation. It also requires maintaining strong relationships with stakeholders and ensuring patient safety through strict regulatory compliance.
The role involves reviewing and approving site visit reports to ensure high quality and compliance with Protocol and SOPs. The manager acts as a liaison between CRAs, CTMs, and PMs to resolve action items and escalate safety trends.
Provide high-level executive support by managing complex calendars, coordinating travel, and handling sensitive information. Serve as the primary point of contact for internal and external stakeholders while supporting special projects and initiatives.
The role involves conducting site visits for clinical trials, including qualification, initiation, monitoring, and close-out. It also requires ensuring protocol compliance, maintaining data integrity, and collaborating with investigators to facilitate study conduct.
The role focuses on coordinating clinical trial delivery, managing budgets, and ensuring effective study oversight. Key duties include mentoring CRAs, driving enrollment, and fostering relationships with sponsors and vendors.
Oversee and manage oncology clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams to ensure accurate data collection.
Lead safety assessments and pharmacovigilance activities for clinical trials and post-marketing surveillance to ensure product efficacy. Coordinate scientific operations, develop team capabilities, and collaborate on risk management strategies.
The specialist is responsible for preparing, verifying, and executing invoicing and reporting for an assigned portfolio of accounts. They must reconcile accounts, investigate discrepancies, and collaborate with the Revenue team to ensure timely billing.
Manage and oversee the processing and tracking of investigator payments to ensure accuracy and compliance with regulatory requirements. Coordinate pricing delivery, resolve payment issues, and develop team capabilities within the clinical research framework.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance and data integrity while collaborating with investigators to maintain high-quality clinical data.
Manage and oversee pharmacovigilance activities, including the collection and processing of adverse event reports and the preparation of periodic safety update reports. Collaborate with medical teams to assess clinical relevance and maintain the integrity of safety databases.
The role involves monitoring pharmaceutical product safety by collecting, analyzing, and reporting adverse event information. Key tasks include conducting signal detection, risk assessments, and preparing regulatory safety reports.
Independently manage the negotiation and execution of clinical trial agreements and budgets for various studies. Collaborate with legal, finance, and project teams to ensure compliant study start-up and maintain accurate negotiation records.
Lead the collection and processing of adverse event reports and conduct safety data analysis to identify potential signals. Prepare regulatory documents like PSURs and oversee the integrity of pharmacovigilance databases while mentoring junior staff.
The role involves coordinating the setup and monitoring of clinical trials while ensuring accurate study status reports and documentation. It requires maintaining strong relationships with investigators and ensuring patient safety through strict regulatory compliance.
Accountable for the end-to-end design, execution, and reporting of global oncology clinical trials. This includes managing study budgets, overseeing vendors, and ensuring compliance with ICH/GCP guidelines.
Accountable for the end-to-end design, execution, and reporting of global oncology clinical trials to ensure delivery within time, budget, and quality standards. This includes managing vendors, ensuring ICH/GCP compliance, and leading cross-functional matrix teams.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. It also requires ensuring protocol compliance, data integrity, and collaborating with investigators to maintain high-quality clinical data.
Implements and monitors oncology clinical trials to ensure compliance with regulatory requirements and ICH GCP guidelines. Manages site startup activities, verifies clinical trial data, and coordinates with investigative sites to resolve trial issues.
Oversee clinical trial management workstreams to ensure quality and timeline expectations are met. Collaborate with cross-functional teams to design protocols and analyze complex medical data to optimize study outcomes.
Develop, validate, and maintain complex statistical programs in R to support clinical trial data analysis and reporting. Take ownership of studies, collaborate with biostatisticians, and mentor junior programmers to ensure regulatory compliance.
Lead site start-up and activation tasks, including feasibility assessments and contract negotiations. Coordinate regulatory and ethics submissions while ensuring patient safety through the review of informed consent forms.
The Senior Local Trial Manager serves as the primary point of communication for clinical sites to streamline operations and ensure trial compliance. They are responsible for site selection, recruitment targets, budget forecasting, and maintaining inspection readiness throughout the trial lifecycle.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Monitor trial sites, conduct site visits, and collaborate with cross-functional teams to ensure data integrity and participant safety.
Lead statistical programming tasks to develop and validate SAS programs for clinical trial data reporting. Collaborate with biostatisticians to define analysis plans and ensure the accuracy of statistical outputs for regulatory submissions.
Monitor the collection and analysis of data from third-party suppliers for sponsored clinical trials. Evaluate supplier compliance, track corrective actions, and maintain professional relationships with stakeholders.
The associate is responsible for the anonymization of clinical trial documents and datasets for public disclosure in compliance with EU CTR, EMA, and Health Canada regulations. This includes developing anonymization plans, applying transformations, and collaborating with biostatistics and regulatory teams to ensure accurate redaction.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols and ensure regulatory compliance.
Support the management of clinical trial sites by assisting with monitoring activities and ensuring compliance with study protocols. Collaborate with cross-functional teams to maintain accurate records and prepare monitoring reports.
Support the management of clinical trial sites by assisting with monitoring activities and ensuring compliance with study protocols and GCP guidelines. Maintain accurate site records, track performance metrics, and collaborate with cross-functional teams to resolve site-related issues.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
Lead a team providing radiation dosimetry services and develop systems for analyzing nuclear medicine images to assess absorbed radiation doses in radioligand therapy trials. Direct medical affairs activities, design image acquisition protocols, and oversee radiation safety and clinical trial data analysis.
The role involves preparing high-quality medical imaging documentation, such as Site Imaging Manuals and Review Charters, to support clinical trials and regulatory submissions. The writer will collaborate with internal teams and sponsors to ensure accurate image acquisition and assessment criteria.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
Lead the Client Engagement team to foster strong client relationships and ensure high levels of satisfaction. Oversee account management workstreams and implement strategies to drive client retention and service excellence.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance and data integrity while collaborating with investigators to maintain high-quality clinical data.
Lead and coordinate project activities to ensure delivery on time, within budget, and to high quality standards. Focus on managing detailed project plans, leading cross-functional teams, and engaging with stakeholders to align with organizational goals.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. It also requires ensuring protocol compliance, data integrity, and collaborating with investigators to maintain high-quality clinical data.
The role involves coordinating and administering clinical trials while ensuring compliance with protocols and regulatory requirements. Key tasks include maintaining study documentation and collaborating with cross-functional teams to track trial milestones.
Oversee pharmacovigilance and drug safety operations to ensure the safety and efficacy of clinical trials. Manage the safety team to ensure accurate reporting of adverse events and implement policies to enhance risk management.
The role involves monitoring pharmaceutical product safety by collecting, analyzing, and reporting adverse event information. Key tasks include conducting signal detection, risk assessments, and preparing regulatory safety reports.
Responsible for defining and implementing global CMC regulatory strategies for a large pharma portfolio throughout clinical development and product lifecycle. This includes managing high-quality regulatory submissions and negotiating with health authorities like the FDA to ensure product approval.
Lead the development and execution of medical writing strategies, including the preparation of clinical study protocols, reports, and regulatory submissions. Collaborate with cross-functional teams to analyze clinical trial data and mentor junior medical writers to ensure high-quality scientific documentation.
Responsible for the anonymization of clinical trial documents and datasets for public disclosure in compliance with EU CTR, EMA Policy 0070, and Health Canada PRCI. This includes developing anonymization plans, mitigating re-identification risks, and collaborating with biostatistics and regulatory operations teams.
Serve as the primary contact between investigational sites and sponsors while conducting various site visits to ensure compliance. Responsibilities include monitoring patient safety, overseeing drug accountability, and managing data quality and site documentation.
The role involves serving as the lead biostatistician for clinical studies, developing statistical analysis plans, and reporting specifications. Responsibilities include performing statistical analyses, interpreting complex medical data, and managing CRF design and randomization schemes.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Lead monitoring tasks, conduct site visits, and collaborate with cross-functional teams for accurate data collection.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. They ensure protocol compliance, data integrity, and patient safety while collaborating with investigators and site staff.
Oversee daily operational activities and lead teams to ensure the successful execution of clinical trials and research projects. Develop standard operating procedures and collaborate with cross-functional teams to optimize workflows and maintain regulatory compliance.
Serve as the primary contact between investigational sites and sponsors while conducting various site visits to ensure compliance with ICH-GCP and SOPs. Responsibilities include monitoring patient safety, overseeing drug accountability, and managing data entry and site documentation.
Lead strategic oncology drug development program design and protocol development for solid tumors and hematologic malignancies. Serve as a scientific partner and trusted advisor to senior industry stakeholders while leading proposal development and bid defense activities.
Lead quality assurance and compliance tasks to ensure pharmaceutical logistics meet regulatory requirements and industry standards. This includes conducting regular audits, managing quality control procedures, and collaborating with cross-functional teams for continuous improvement.
Manage clinical trial operations activities, including budget oversight and the development of monitoring plans to ensure high-quality outcomes. Coordinate study start-up, drive enrollment, and mentor Clinical Research Associates to optimize performance.
Drive revenue for the Patient Centered Sciences group by selling ECOA and regulatory consulting services. Manage the full sales lifecycle from lead generation to contract closure while maintaining strong client relationships.
The Program Manager ensures that clinical data science goals and deliverables meet quality standards, timelines, and contractual requirements. They provide technical leadership, manage project finances, and oversee the delivery of multiple client programs.
The Senior Local Trial Manager serves as the primary point of communication for sites and manages end-to-end trial lifecycles. Responsibilities include overseeing local vendors, executing milestones from feasibility to close-out, and ensuring country-level inspection readiness.
The Sr. CRA is responsible for managing investigative sites and performing monitoring activities throughout the clinical trial lifecycle to ensure data integrity and subject safety. Key duties include conducting site visits, managing essential documents, and ensuring compliance with protocols and regulatory standards.
The role involves identifying, selecting, and monitoring investigational sites for phase II-IV clinical studies to ensure adherence to ICH-GCP regulations. Responsibilities include managing regulatory submissions, handling sponsor queries, and maintaining study documentation.
Lead the preparation and editing of clinical study documents, including protocols, CSRs, and regulatory submissions. Collaborate with cross-functional teams to analyze clinical trial data and mentor junior medical writers.
Lead all aspects of site management, including selection, initiation, monitoring, and close-out visits to maximize site performance. Act as the primary point of contact for study sites while collaborating with Project Managers to ensure compliance with GCP and regulatory requirements.
Manage the end-to-end delivery of imaging-related projects within clinical trials, ensuring alignment with goals and timelines. Oversee project budgets, resources, and compliance with regulatory standards and imaging protocols.
The Principal Biostatistician leads statistical activities for clinical trials, including designing studies and interpreting complex medical data. They are responsible for reviewing statistical methods, managing budgets, and interacting with clients and regulatory agencies.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams and investigators to implement protocols and maintain regulatory compliance.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. It also requires ensuring protocol compliance, data integrity, and collaborating with investigators to maintain high-quality clinical data.
Clinical Research Associate II/Senior Clinical Research Associate
ICON plc
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Full Time
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a month ago
ICON plc
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Responsibilities include ensuring protocol compliance, maintaining data integrity, and collaborating with investigators to facilitate study conduct.
Lead and coordinate clinical project activities to ensure delivery on time, within budget, and according to quality standards. Responsibilities include managing project plans, leading cross-functional teams, and engaging with stakeholders to align with organizational goals.
Provide operational and administrative support to the Clinical Trial Supply Manager, focusing on packaging, labeling, and downstream logistics. Manage logistical requirements in the ESR system, track shipments, and ensure proper documentation in the electronic trial master file.
Lead biostatistician responsible for designing and analyzing clinical trials and overseeing statistical activities for clients and regulatory agencies. Duties include programming in SAS/R, reviewing study protocols, and mentoring junior statisticians.
The Senior CRA is responsible for monitoring clinical trials onsite or remotely to ensure data integrity, patient safety, and compliance with protocols and regulatory requirements. They also support complex studies, maintain site readiness for audits, and mentor junior staff.
Lead strategic drug development program design and protocol development for various liver diseases across Phases I–IV. Serve as a scientific partner and trusted advisor to senior industry stakeholders and internal teams to drive Hepatology growth.
Lead the design, development, and deployment of innovative clinical training programs and educational materials for employees and stakeholders. Manage project timelines, budgets, and compliance oversight while partnering with subject matter experts to identify training needs.
The role involves planning and managing Feasibility and Site Activation (FSA) activities for clinical studies, including overseeing site start-up workstreams. Key duties include coordinating feasibility assessments, managing regulatory submissions, and tracking progress against KPIs to ensure quality and timeline expectations are met.
Lead the planning, execution, and delivery of clinical research projects, specifically focusing on precision medicine and targeted oncology programs. Drive project management strategies to enhance efficiency and manage cross-functional teams and external stakeholders.
Lead and manage clinical projects, specifically focusing on radiopharmaceutical and radioligand-based programs. Responsibilities include developing project plans, leading cross-functional teams, and mentoring staff to ensure quality delivery of objectives.
The Clinical Trial Supply Manager serves as the primary point of contact for logistical activities from protocol initiation to final product delivery. They are responsible for designing logistical plans, managing worldwide depots, and ensuring the timely re-supply of investigational products.
Lead the development of high-quality regulatory and clinical documents to support client submissions to regulatory authorities. Coordinate writing assignments, formulate strategies, and provide functional guidance on international regulatory requirements.
Lead the development of high-quality regulatory and clinical documents to support submissions to global regulatory authorities. Manage medical writing projects, including timeline development and cross-functional coordination to ensure compliance with industry standards.
The role involves creating and maintaining detailed data management plans and resolving data discrepancies to ensure high data quality. Additionally, the Senior CDC mentors junior staff and collaborates with cross-functional teams to execute study-specific data strategies.
Lead and manage imaging and CEC projects to ensure successful execution and delivery of project objectives. This includes developing project plans, leading cross-functional teams, and collaborating with stakeholders to define project scope.
Oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and industry standards. Monitor trial sites, conduct visits, and collaborate with cross-functional teams to ensure data integrity and participant safety.
Manage and negotiate contractual agreements for clinical research projects while ensuring alignment with regulatory requirements and company policies. Analyze contract terms to identify risks and provide guidance to project teams on compliance and contractual obligations.
Develop and validate SAS programs for the statistical analysis and reporting of clinical trial data. Collaborate with biostatisticians to define analysis plans and ensure accuracy in regulatory submissions.
Oversee and manage early-phase oncology clinical trial activities to ensure adherence to protocols and regulatory standards. Lead site monitoring visits, collaborate with cross-functional teams, and provide guidance to site staff and other CRAs.
The role involves conducting site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. Additionally, the CRA is responsible for data review, query resolution, and contributing to study documentation and reports.
The specialist is responsible for testing clinical system components and managing UAT documentation and deliverables. They collaborate with stakeholders to interpret study protocols and ensure system functionality supports clinical trials.
The role involves creating and maintaining data management plans and resolving data discrepancies to ensure high data quality throughout the study lifecycle. Additionally, the coordinator collaborates with cross-functional teams and mentors junior staff on cleaning and reconciliation procedures.
Provide medical expertise in the design, execution, and interpretation of oncology clinical trials. Collaborate with cross-functional teams to develop study protocols and maintain relationships with regulatory authorities and key opinion leaders.
The CRA II will independently monitor Phase II-IV clinical trials for a global pharmaceutical partner, ensuring compliance with ICH-GCP and sponsor SOPs. Key tasks include conducting site visits, managing study documentation, and maintaining strong relationships with investigators across various therapeutic areas.
The Clinical Research Associate will conduct site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. They will also collaborate with site staff and manage clinical data to maintain high-quality study documentation.
The Project Manager will oversee IRT system activities from award to closeout, ensuring projects remain within timeline and budget. They will facilitate stakeholder communication, manage requirement designs, and identify risks to create effective action plans.
The Senior Clinical Trial Manager is responsible for overseeing the clinical budget, developing monitoring plans, and driving study enrollment. They also lead study start-up activities, mentor Clinical Research Associates, and ensure study integrity through effective risk mitigation and stakeholder liaison.
The Senior Clinical Editor is responsible for ensuring the accuracy, clarity, and quality of scientific documents, including clinical study reports and regulatory submissions. They will also mentor junior staff and collaborate with medical writers to maintain high standards of scientific communication.
The Biostatistician II assists senior staff with clinical study support, including study design, sample size calculations, and patient randomization. They are also responsible for developing statistical analysis plans, manipulating data, and preparing statistical summary reports for clinical research projects.
The Clinical Research Associate will conduct site monitoring visits to ensure protocol compliance, data integrity, and patient safety. They will also collaborate with investigators and site staff to facilitate study conduct and manage clinical trial documentation.
Manage day-to-day clinical trial operations, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams to implement protocols and maintain strong relationships with investigators and stakeholders.
The Biomarker Lead Statistician will design and analyze clinical trials while interpreting complex medical data. They are responsible for developing statistical analysis plans, leading biomarker output deliverables, and overseeing statistical aspects of CRF design.
The Clinical Research Associate will coordinate study setup, monitoring, and site management activities while ensuring adherence to ICH-GCP regulations. They will also handle regulatory submissions, maintain study documentation, and provide mentorship to less experienced team members.
The Clinical Research Associate serves as the primary point of contact for investigational sites, ensuring compliance with ICH-GCP and regulatory standards. They are responsible for conducting site visits, monitoring patient safety, managing documentation, and overseeing drug accountability.
The Senior Clinical Research Associate monitors clinical study progress at investigative sites or remotely to ensure compliance with protocols and regulatory requirements. They are responsible for ensuring that clinical trials are accurately conducted, recorded, and reported according to SOPs and ICH-GCP standards.
The Senior Clinical Research Associate monitors clinical study progress at investigative sites or remotely to ensure compliance with protocols and regulatory requirements. They are responsible for ensuring that clinical trials are accurately recorded and reported in accordance with ICH-GCP and standard operating procedures.
The Senior CRA will oversee clinical trial monitoring activities to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice standards. They will also conduct site visits, manage site performance, and collaborate with cross-functional teams to ensure accurate data collection.
The Clinical Research Associate serves as the primary point of contact for investigational sites, ensuring compliance with ICH-GCP and regulatory standards. They are responsible for conducting site visits, monitoring patient safety, managing data integrity, and overseeing drug accountability.
The Clinical Research Associate is responsible for conducting site visits, ensuring protocol compliance, and maintaining data integrity throughout clinical trials. They also collaborate with investigators and contribute to the preparation of essential study documentation.
The Clinical Research Associate is responsible for conducting site visits, ensuring protocol compliance, and maintaining data integrity throughout clinical trials. They also collaborate with investigators and site staff to facilitate study conduct and prepare essential study documentation.
The Clinical Trial Manager oversees the planning, execution, and successful completion of clinical trials while ensuring adherence to timelines, budgets, and regulatory standards. They collaborate with cross-functional teams and manage relationships with investigators to drive successful trial outcomes.
The Senior CRA will oversee clinical trial activities to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice standards. They are responsible for conducting site visits, managing data collection, and providing training to site staff to ensure successful trial execution.
The TMF Lead is responsible for overseeing Trial Master File management processes to ensure regulatory compliance and document integrity. They will collaborate with cross-functional teams, conduct quality audits, and implement strategies for continuous process improvement.
You will conduct clinical trial monitoring activities including site visits, protocol compliance, and data integrity maintenance. Additionally, you will collaborate with investigators and site staff to facilitate study conduct and prepare essential study documentation.
The Senior Clinical Research Associate will conduct site qualification, monitoring, and close-out visits while ensuring protocol compliance and data integrity. They will also collaborate with investigators and contribute to the preparation of study documentation and clinical reports.
The Process & Quality Document Manager supports process design, documentation development, and quality compliance for Global Development Operations. They are also responsible for coordinating training assignments, managing quality document reviews, and supporting audit and inspection processes.
The specialist will drive study initiation activities including feasibility assessments, site identification, and contract negotiations. They will also ensure regulatory compliance and manage ethics submissions to support the efficient progression of clinical trials.
The Clinical Research Associate is responsible for conducting site qualification, monitoring, and close-out visits to ensure protocol compliance and patient safety. They also collaborate with site staff to facilitate study conduct and perform data review to maintain high-quality clinical data.
The Senior Clinical Research Associate is responsible for conducting site visits, ensuring protocol compliance, and maintaining data integrity throughout clinical trials. They also collaborate with site staff and investigators to facilitate study conduct and prepare essential study documentation.
The role involves conducting site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. Additionally, the CRA will collaborate with site staff and perform data review to maintain high-quality clinical trial documentation.
Monitor the progress of clinical studies at investigative sites or remotely to ensure compliance with protocols and regulatory requirements. Maintain accurate records and reports in accordance with ICH-GCP and standard operating procedures.
You will oversee and manage clinical trial activities to ensure adherence to protocols, regulatory requirements, and Good Clinical Practice standards. This involves conducting site visits, collaborating with cross-functional teams, and providing training to site staff to ensure successful trial execution.
The Clinical Research Associate serves as the primary point of contact for investigational sites, conducting site visits to ensure compliance with ICH-GCP and regulatory standards. They are responsible for monitoring patient safety, managing site documentation, and overseeing drug accountability throughout the clinical trial process.
The Country Study Operations Manager leads and coordinates study activities from startup through conduct and close, ensuring projects meet quality, budget, and timeline standards. They oversee local study teams, manage vendor relationships, and ensure compliance with global and local regulatory requirements.
The Senior CRA is responsible for monitoring clinical trial sites to ensure adherence to protocols, regulatory requirements, and Good Clinical Practice standards. They also collaborate with cross-functional teams to ensure accurate data collection and provide training to site staff to maintain high standards of trial conduct.
The Senior Clinical Trial Manager is responsible for overseeing the clinical portion of study budgets, developing monitoring plans, and driving enrollment to meet project objectives. They also lead study start-up activities, mentor Clinical Research Associates, and ensure the integrity of clinical data through rigorous oversight.
The Clinical Research Associate II is responsible for conducting site visits, ensuring protocol compliance, and maintaining data integrity throughout clinical trials. They also collaborate with site staff and investigators to facilitate study conduct and prepare essential study documentation.
Provide strategic medical leadership and expert scientific guidance to project teams throughout the clinical development lifecycle. Ensure all medical and safety activities remain in compliance with ethical, legal, and regulatory standards.
The Senior Project Manager will lead and manage day-to-day project activities, ensuring successful execution and delivery of objectives. They will also mentor team members and collaborate with stakeholders to define project requirements and scope.
You will conduct clinical trial monitoring activities, including site visits and documentation, to ensure protocol compliance and data integrity. Additionally, you will collaborate with investigators and site staff to facilitate smooth study conduct and maintain high-quality clinical data.
The Medical Director provides strategic medical leadership and expert scientific guidance to project teams throughout the clinical development lifecycle. They ensure compliance with regulatory and ethical standards while representing the Medical Affairs department in business development initiatives.
Oversee and coordinate the end-to-end preparation, negotiation, and execution of clinical trial agreements and budgets. Act as a primary escalation point for contract issues while collaborating with legal, finance, and project teams to ensure alignment.
The Clinical Research Physician provides medical leadership and data review support for clinical trials to ensure adherence to ethical and regulatory standards. Responsibilities include monitoring clinical trial data, identifying protocol deviations, and providing medical input into clinical and statistical reports.
The Senior Global Regulatory Scientist will lead the development of global regulatory strategies and author complex regulatory documents for clinical programs. They will also provide strategic input into clinical development plans and represent regulatory functions in interactions with health authorities and sponsors.
The Senior Clinical Research Associate will monitor clinical trial sites to ensure adherence to protocols, regulatory requirements, and Good Clinical Practice standards. They will also collaborate with cross-functional teams to ensure data integrity and provide training to site staff to maintain high standards of trial conduct.
You will manage day-to-day clinical trial operations, ensuring adherence to timelines, budget, and quality standards. You will also collaborate with cross-functional teams to implement protocols and manage relationships with investigators and stakeholders.
The Senior CRA oversees clinical trial monitoring activities to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice standards. They also collaborate with cross-functional teams and provide training to site staff to facilitate successful trial execution.
You will conduct clinical trial monitoring activities, including site qualification, initiation, and close-out visits to ensure protocol compliance and patient safety. Additionally, you will collaborate with site staff and investigators while performing data review to maintain high-quality clinical documentation.
The Clinical Research Associate II is responsible for conducting site monitoring visits, ensuring protocol compliance, and maintaining data integrity throughout clinical trials. They also collaborate with investigators and site staff to facilitate study conduct and prepare essential study documentation.
The Principal Programmer will act as a lead across complex clinical studies, taking ownership of deliverables and collaborating with biostatisticians to translate analysis plans into robust R programs. They will also serve as a technical leader, mentoring staff and driving the modernization of programming approaches within a regulated environment.
The Senior CRA oversees clinical trial activities to ensure adherence to protocols, regulatory requirements, and Good Clinical Practice standards. They conduct site visits, manage site performance, and collaborate with cross-functional teams to ensure accurate data collection and reporting.
The specialist will prepare, verify, and execute invoicing for an assigned portfolio of accounts while maintaining client relationships. They will also reconcile accounts, investigate discrepancies, and collaborate closely with the Revenue team.
Manage day-to-day clinical trial operations to ensure adherence to timelines, budget, and quality standards. Collaborate with cross-functional teams and stakeholders to implement protocols and ensure regulatory compliance.
The role involves conducting clinical trial monitoring activities including site visits, protocol compliance, and data integrity maintenance. You will also collaborate with investigators and site staff while preparing and reviewing essential study documentation.
You will oversee and manage clinical trial activities to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice standards. This includes conducting site visits, collaborating with cross-functional teams, and providing training to site staff to ensure successful trial execution.
Conduct site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. Collaborate with site staff and investigators while performing data review to maintain high-quality clinical documentation.
Clinical Research Associate II/Senior Clinical Research Associate
ICON plc
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Full Time
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3 months ago
ICON plc
You will conduct clinical trial monitoring activities, including site qualification, initiation, and close-out visits. Additionally, you will ensure protocol compliance, maintain data integrity, and collaborate with investigators to facilitate smooth study conduct.
The Head of Patient Recruitment will lead and manage the patient recruitment team while developing strategic initiatives to advance clinical trial enrollment. This role involves P&L management, fostering external partnerships, and leveraging technology and data to optimize recruitment performance.
The Project Specialist will support global study teams by managing budgets, vendor oversight, and ensuring data completeness within the eTMF. They are responsible for monitoring study progress, maintaining regulatory compliance, and coordinating with internal and external partners.
The Manager of Clinical Operations is responsible for overseeing the operational planning and execution of clinical trials to ensure they meet regulatory standards and timelines. They will also lead cross-functional teams, monitor performance metrics, and mentor staff to foster a culture of excellence.
The Senior Clinical Trial Associate will support the management and execution of clinical trials by handling administrative and operational tasks. This includes coordinating meetings, maintaining trial records, and ensuring regulatory compliance through effective communication with cross-functional teams.
The Project Manager will shape and execute Study Start-Up strategies for global clinical studies, ensuring alignment with timelines and sponsor expectations. They will oversee regulatory submissions, manage site contracts, and drive end-to-end start-up activities.
The Senior CRA will oversee and manage clinical trial activities to ensure compliance with protocols and regulatory requirements. Responsibilities include monitoring sites, conducting visits, and collaborating with teams to ensure data integrity and participant safety.
The Clinical Research Associate II will conduct site qualification, initiation, monitoring, and close-out visits for clinical trials. They will ensure protocol compliance, data integrity, and patient safety throughout the trial process.
The Clinical Data Coordinator will oversee the collection, management, and quality of clinical trial data, ensuring compliance with regulatory requirements and project timelines. Key duties include coordinating data collection, managing data entry, performing quality control checks, and collaborating with cross-functional teams to resolve data issues.
The Senior CRA will oversee and manage clinical trial activities, ensuring adherence to protocol, regulatory requirements, and industry standards across monitored sites. This involves conducting site visits, resolving issues, ensuring timely data collection, and providing guidance to site staff.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials while ensuring protocol compliance, data integrity, and patient safety throughout the process. Responsibilities also include collaborating with site staff, performing data review and query resolution, and contributing to the preparation and review of study documentation.
The Senior Pharmacovigilance Associate will lead the collection, evaluation, and processing of adverse event reports, ensuring timely and accurate reporting according to regulations. This role involves conducting thorough data analysis to identify safety signals and preparing comprehensive periodic safety update reports (PSURs).
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials while ensuring protocol compliance, data integrity, and patient safety. Responsibilities also include collaborating with investigators, performing data review, and contributing to the preparation and review of study documentation.
The specialist will contribute to delivering clinical studies on time, cost, and quality by overseeing eTMF completeness and managing budgets, including task orders and expenses. Responsibilities also include country oversight, vendor management, data oversight, reviewing key clinical documents, and maintaining study systems and tracking tools.
Sr Project Manager - Medical Affairs & Evidence Generation
ICON plc
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Full Time
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3 months ago
ICON plc
The Senior Project Manager will be responsible for leading and managing projects, ensuring successful execution and delivery of project objectives, which includes developing and executing project plans focused on achieving goals. This role involves leading cross-functional teams, collaborating with stakeholders, mentoring team members, and driving the development of project documentation and reports.
The Senior CRA will oversee and manage clinical trial activities, ensuring adherence to protocol, regulatory requirements, and industry standards across monitored sites. Responsibilities include conducting site visits, resolving issues, providing guidance to site staff, and collaborating cross-functionally for timely data collection.
The Global Study Lead is responsible for ensuring the successful delivery of all clinical aspects of studies, which includes overseeing the clinical budget, developing monitoring plans, and driving enrollment to meet project objectives. This role also involves reviewing trip reports, implementing corrective actions, and fostering productive relationships with sponsors and cross-functional teams.
The Global Study Lead is responsible for ensuring the successful delivery of all clinical aspects of studies, which includes overseeing the clinical budget, developing monitoring plans, and driving enrollment to meet project objectives. This role also involves liaising with stakeholders, identifying and mitigating risks, and providing comprehensive reporting on clinical activities.
The Senior CRA will monitor clinical trial sites to ensure strict adherence to study protocols, regulatory standards, and GCP guidelines, while conducting site visits to resolve issues and support successful trial execution. This role also involves collaborating with cross-functional teams, providing guidance to site staff and other CRAs, and building strong relationships with site personnel.
This leadership role involves supporting the statistical aspects of clinical and preclinical research projects, including assistance with case report form development, data analysis, and reporting of results under senior supervision. Key duties include assisting senior biostatisticians with study design, sample size calculations, randomization, and contributing to statistical analysis plans and integrated study reports.
The Clinical Trial Manager will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. This role involves collaborating with cross-functional teams, managing site relationships, and providing strategic guidance to drive successful trial outcomes.
The Principal Biostatistician will lead the statistical strategy and execution for Phase I–III oncology programs and individual studies, ensuring scientific and regulatory excellence through review of protocols, SAPs, and clinical reporting. This role also involves providing statistical guidance to clients, supporting agency interactions, and mentoring junior staff.
The Clinical Research Associate will oversee and manage clinical trial activities, ensuring adherence to protocol, regulatory requirements, and industry standards across various sites. This includes conducting site visits, resolving issues, ensuring timely data collection, and providing guidance to site staff.
The Senior CRA will monitor clinical trial sites to ensure strict adherence to study protocols, regulatory requirements, and GCP standards, while also conducting site visits to assess performance and resolve operational issues. They will collaborate with internal teams, provide guidance to site staff, and build strong relationships with stakeholders to ensure timely and accurate data collection and smooth trial execution.
The Senior Clinical Trial Manager will ensure the successful delivery of all clinical aspects of studies, which includes overseeing the clinical budget, developing monitoring plans, and driving enrollment to meet project objectives. Key duties also involve training CRAs, reviewing reports, implementing corrective actions, and fostering relationships with sponsors and cross-functional teams.
The Senior CRA will oversee and manage clinical trial activities, ensuring adherence to protocol, regulatory requirements, and industry standards across monitored sites. This involves conducting site visits, resolving issues, providing guidance to site staff, and ensuring timely and accurate data collection.
The Medical Data Reviewer will review clinical data listings, visualizations, and patient profiles for medical plausibility and consistency, while also supporting the creation and assurance of consistency for the Medical Data Review Plan across project documents. Key tasks include coordinating eCRF review, participating in meetings, solving technical problems, reviewing for protocol deviations, and ensuring activities meet quality standards and timelines.
The Senior Clinical Research Associate will support a study in the cardiovascular/electrophysiology medical device space, specifically focusing on A-fib indication. This involves monitoring experience, applying in-depth knowledge of regulations, and implementing effective solutions for site issues.
The Senior Clinical Research Associate will support a study in the cardiovascular/electrophysiology medical device space, specifically focusing on A-fib indication. This involves monitoring experience, applying in-depth knowledge of regulations, and implementing solutions for site issues.
The Senior CRA will monitor clinical trial sites to ensure adherence to protocols, regulatory requirements, and GCP standards, while conducting site visits to assess performance and resolve issues. They will also collaborate with cross-functional teams, provide training to site staff, and build effective relationships with personnel and stakeholders.
The manager will lead regulatory activities and submissions independently, providing regulatory guidance and operational support across various stages of drug development, including agency interactions and clinical trial applications. They will also contribute to developing best practices within ICON Regulatory Affairs based on regulatory process insights.
The Site Management Associate I will assist in monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and GCP guidelines. This role involves supporting site management activities such as documentation, data entry, tracking performance metrics, and collaborating with teams to resolve site-related issues.
The Clinical Trial Manager will oversee the planning, execution, and successful completion of clinical trials while ensuring adherence to timelines, budgets, and regulatory guidelines. This role involves collaborating with cross-functional teams and managing site relationships to drive successful clinical trial outcomes.
The Global Clinical Project Specialist will be a key member of the sponsor's Global Study Team, responsible for delivering clinical studies on time, within budget, and ensuring quality. This includes oversight of study eTMF completeness, budget management, vendor management, and data oversight.
The Clinical Research Associate will conduct site qualification, initiation, monitoring, and close-out visits for clinical trials while ensuring protocol compliance and patient safety. They will also collaborate with investigators and site staff to facilitate smooth study conduct and perform data review.
The Site Management Associate will coordinate monitoring activities at clinical trial sites and assist in ensuring compliance with study protocols and regulatory requirements. They will also track site performance metrics and provide reports to enhance site management efficiency.
The Clinical Trial Liaison supports clinical trials by providing scientific and clinical support to investigators and site staff. They also function as recruitment specialists to develop and optimize strategies for successful patient enrollment.
Assist project managers in planning, execution, and monitoring of clinical trials. Coordinate study activities including site selection, patient recruitment, and data collection.
The Site Specialist II will work with Site Partners and internal stakeholders to optimize study performance and ensure successful site activation. They will support the collection and organization of start-up documentation and ensure compliance with applicable regulations and guidelines.
Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials while ensuring protocol compliance and patient safety. Collaborate with investigators and site staff to facilitate smooth study conduct and maintain high-quality clinical data.
The Clinical Trial Liaison supports clinical trials by providing scientific and clinical support to investigators and site staff. They also function as recruitment specialists, developing strategies to drive successful patient enrollment.
Lead clinical trial start-up activities and oversee day-to-day delivery of site activation in assigned projects. Ensure adherence to sponsor timelines and compliance with regulatory standards.
