Lead study-level vendor set-up and readiness activities to ensure the quality and integrity of data generated by external clinical research vendors. Translate protocol requirements into vendor specifications and manage the interface between the study team and vendors.
ICON plc
438 Remote Job Openings at ICON plc
Lead the design and implementation of advanced data science methodologies and statistical models to optimize clinical research and trial outcomes. Coordinate delivery, guide a team of data scientists, and communicate complex insights to senior leadership and stakeholders.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits for oncology clinical trials. They ensure protocol compliance and data integrity while collaborating with investigators to maintain high-quality clinical data.
Support the negotiation and administration of master clinical trial agreements and site budgets. Coordinate with internal teams and external sites to ensure prompt contract execution and adherence to study timelines.
Serve as the primary contact between investigational sites and the sponsor while conducting various site visits to ensure compliance with ICH-GCP and SOPs. Oversee patient safety reporting, drug accountability, and high-quality data entry within CTMS and eTMF systems.
Serve as the primary contact between investigational sites and the sponsor 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.
Serve as the primary contact between investigational sites and the sponsor 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.
Lead a data science team to deliver advanced analytics and business transformation for clinical trial feasibility and site activation. Develop strategic roadmaps for forecasting, risk prediction, and optimization to improve clinical development cycle times.
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.
Responsible for the strategic planning, tactical execution, and day-to-day management of clinical investigations involving human subjects. This includes overseeing trial compliance, managing vendors and CROs, and ensuring adherence to global regulatory standards.
Coordinate and execute centralized review activities, including imaging and laboratory assessments for clinical trials. Collaborate with study teams and vendors to ensure accurate data collection and adherence to regulatory standards.
Develop and maintain programming solutions for data analysis and reporting within clinical trials. Oversee the generation of statistical datasets, tables, listings, and figures for regulatory submissions.
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.
Manage clinical trial operations, including budget oversight, study start-up, and enrollment activities. Coordinate with sponsors and vendors while mentoring Clinical Research Associates to ensure high-quality trial outcomes.
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 role involves providing administrative and operational support for clinical trials, including managing documentation and coordinating regulatory submissions. The CTA will also monitor trial progress and maintain strong relationships with site staff and stakeholders.
The role involves managing clinical trial deliverables, including administrative support, regulatory submissions, and trial record maintenance. It also requires coordinating with cross-functional teams and site staff to monitor trial progress and ensure operational success.
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.
Lead the end-to-end Study Start-Up (SSU) strategy and execution to ensure efficient site activation and regulatory compliance for global clinical studies. Coordinate cross-functional teams, manage site contracts and budgets, and provide strategic reporting to sponsors and internal leadership.
Lead and manage healthcare intelligence and clinical research 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 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 coordinate global 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 across cross-functional teams.
The Global Study Manager coordinates clinical trial delivery, manages budgets, and ensures effective study oversight. They are responsible for driving enrollment, mentoring CRAs, and maintaining productive relationships with sponsors and vendors.
The role involves conducting site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. Additionally, the CRA will perform data review and collaborate with investigators to maintain high-quality clinical data.
Lead and coordinate global 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 stakeholders to align with organizational goals.
Manage country-level clinical study activities from startup through close, ensuring operational delivery according to quality and regulatory standards. Coordinate with local teams, vendors, and CROs to drive recruitment, site activation, and data cleaning deliverables.
Accountable for driving the activation of global investigative sites within contractual timelines and budgeted resources. Coordinates implementation of site activation activities including regulatory ethics, contracts, and essential documents.
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.
Conduct site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. Collaborate with investigators and perform data review to maintain high-quality clinical data and study documentation.
Lead the design and execution of clinical trial protocols while ensuring compliance with regulatory and GCP standards. Monitor patient safety and collaborate with cross-functional teams to provide medical insights for study data analysis.
Oversee resource forecasting, allocation, and utilization to ensure efficient delivery of clinical projects. Lead demand forecasting and capacity analysis while collaborating with functional leaders to balance workloads.
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 and optimize the allocation and utilization of resources to support clinical trials and pharmaceutical projects. Collaborate with project managers to develop allocation plans and monitor resource availability to mitigate risks.
Oversee the implementation and management of Interactive Response Technology (IRT) solutions for clinical trials. Manage project planning, execution, and delivery while collaborating with cross-functional teams to ensure alignment with regulatory standards.
The role involves managing administrative and operational tasks for clinical trials, including documentation and regulatory submissions. It also requires collaborating with cross-functional teams and maintaining relationships with site staff to ensure trial success.
Facilitate site budget and contract negotiations to ensure prompt execution and adherence to study timelines. Manage clinical trial agreements and collaborate with internal teams and CROs to improve SB&C metrics.
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.
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 CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. They collaborate with investigators to maintain high-quality clinical data and contribute to the preparation of study documentation.
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, monitoring performance metrics, and supporting CRAs throughout the study process.
Lead and coordinate clinical project activities to ensure delivery on time, within budget, and to high quality standards. Focus on managing project plans, resolving issues, and developing team capability within a sponsor-dedicated model.
Oversee clinical data science workstreams to ensure quality deliverables and implement strategies for optimized data collection and reporting. Lead cross-functional collaboration to integrate data science techniques into clinical trial designs and provide strategic guidance on data governance.
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 role involves conducting site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. Additionally, the CRA will perform data review and collaborate with investigators to maintain high-quality clinical data.
Senior Study Manager - Infectious Disease/Vaccines (Pragmatic trials) - US/Canada
ICON plc
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Full Time
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5 days ago
ICON plc
The Senior Study Manager will lead or support clinical trials, managing operational activities and ensuring trial deliverables are met. Responsibilities include overseeing trial execution, managing clinical trial teams, and ensuring compliance with protocols and budgets.
The role involves facilitating the initiation of clinical trials and ensuring compliance with regulatory requirements. Key responsibilities include preparing and submitting regulatory documents and coordinating with stakeholders for study initiation.
Support the management of clinical trial sites by assisting with monitoring activities and ensuring adherence to study protocols and GCP guidelines. Collaborate with cross-functional teams to maintain accurate records and address site-related issues effectively.
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 patient safety through strict adherence to protocols and regulatory requirements.
Lead and direct Clinical Data Science project teams through the initiation, planning, and closing of clinical trial systems. Support business development efforts and manage client deliverables, timelines, and system integration.
The role involves conducting remote review and analysis of clinical trial data to identify risks to patient safety and data quality. You will collaborate with site personnel to implement corrective actions and optimize centralized monitoring strategies.
Manage the end-to-end grant application process, including identifying opportunities and developing compelling proposals. Ensure compliance with funding requirements and track grant outcomes to support clinical programmes.
The role involves conducting remote review and analysis of clinical trial data to identify risks to patient safety and data quality. You will collaborate with site personnel to implement corrective actions and optimize centralized monitoring strategies.
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 and maintain regulatory compliance.
Lead the development and oversight of informed consent strategies and documents for complex global clinical studies. Act as a subject matter expert to ensure participant materials are ethical, compliant, and understandable across different regions.
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 standards of regulatory compliance.
Oversee global pharmacovigilance activities to ensure the safety and efficacy of clinical trials through the delivery of innovation and excellence projects. Lead transformational initiatives including process updates, automation, and the maintenance of the Patient Safety Master File.
Lead and manage biometrics project teams to ensure the successful execution of clinical trials within budget and quality standards. Coordinate with cross-functional teams to implement data management and statistical analysis plans while serving as the primary contact for clients and regulatory authorities.
Lead and coordinate global cross-functional projects to ensure delivery on time, within budget, and according to quality standards. Responsibilities include managing detailed project plans, monitoring progress, and engaging with stakeholders to align with organizational objectives.
The role involves coordinating the setup and monitoring of clinical trials while maintaining accurate study documentation and status reports. It also requires managing stakeholder relationships and ensuring patient safety through strict adherence to protocols and regulatory requirements.
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.
Serve as the primary contact between investigation sites and sponsors for early development multi-therapeutic clinical trials. Responsibilities include conducting site visits, ensuring regulatory compliance, and overseeing patient safety and drug accountability.
Support the management and monitoring of clinical trial sites to ensure compliance with study protocols and regulatory requirements. Coordinate site activities, track performance metrics, and collaborate with cross-functional teams throughout the study lifecycle.
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 to ensure accurate data collection.
Lead the development and implementation of quality assurance strategies to ensure compliance of clinical trials with regulatory standards. Collaborate with cross-functional teams to identify quality issues and drive continuous improvement of quality management systems.
The Associate Medical Director provides medical expertise in the design, execution, and interpretation of oncology clinical trials. Key duties include collaborating on study protocols, providing medical oversight for safety and data, and maintaining relationships with regulatory authorities and key opinion leaders.
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 data integrity and participant safety.
The role involves conducting site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. Additionally, the CRA II is responsible for performing data reviews and collaborating with investigators to maintain high-quality clinical data.
Oversee the implementation and management of Interactive Response Technology (IRT) solutions for clinical trials. Manage project planning, execution, and delivery while collaborating with cross-functional teams to ensure alignment with regulatory standards.
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.
Develop, validate, and maintain complex statistical programs for data manipulation and reporting in clinical trials. Collaborate with biostatisticians to implement statistical analyses and mentor junior programmers on best practices.
The role involves coordinating and monitoring clinical trials to ensure high-quality outcomes and patient safety. Key duties include managing study documentation, running sponsor queries, and maintaining relationships with clinical investigators and site staff.
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.
The role involves coordinating and administering clinical trials while ensuring strict compliance with protocols and regulatory requirements. Key tasks include maintaining essential study documentation and collaborating with cross-functional teams to ensure smooth trial execution.
The CRA is responsible for conducting site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. They will also perform data review and collaborate with investigators to maintain high-quality clinical data.
Lead the analysis, interpretation, and management of clinical data across multiple studies to drive clinical trial success. Oversee data science workstreams, develop data management strategies, and collaborate with cross-functional teams to ensure quality and regulatory compliance.
The role involves coordinating the setup and monitoring of clinical trials while maintaining accurate study documentation and status reports. It also requires managing relationships with clinical investigators and ensuring patient safety through strict regulatory compliance.
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 the end-to-end management of clinical document translation projects, ensuring quality, compliance, and timely delivery. Drive the implementation and optimization of AI-enabled translation platforms and manage relationships with external vendors and internal stakeholders.
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.
Oversee regulatory affairs operations and develop strategies for global clinical trials. Lead interactions with regulatory agencies and ensure compliance with industry trends and requirements.
Manage the end-to-end delivery of imaging-related projects within clinical trials, ensuring they are completed on time and within scope. Coordinate cross-functional teams and oversee budgets and resources while maintaining compliance with regulatory and quality standards.
Lead the end-to-end study start-up strategy and execution for assigned clinical trials. Manage site activation timelines, regulatory requirements, and cross-functional stakeholder partnerships to ensure efficient study launch.
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 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 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 identifying and mitigating risks associated with clinical trial data to ensure data quality and integrity. Key duties include leading data evaluations, collaborating with cross-functional teams, and providing guidance on data governance.
Manage day-to-day global 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.
The role involves designing and analyzing clinical trials by managing eCRF maintenance and data validation specifications. You will also handle clinical and third-party data reconciliation while tracking study metrics and resolving data issues.
Support the management and monitoring of clinical trial sites to ensure compliance with study protocols and regulatory requirements. Coordinate monitoring activities, track performance metrics, and collaborate with cross-functional teams throughout the study lifecycle.
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 risks and maintaining accurate contract records.
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.
Lead the development and analysis of pricing strategies and investigator payments for clinical trials. Collaborate with finance and clinical operations teams to create accurate pricing models and optimize costs.
Establish and manage relationships with investigational sites to promote clinical development projects and build company networks. Oversee site-level study start-up, conduct, and close-out activities while ensuring compliance with regulatory requirements.
Lead the design, execution, and analysis of clinical trials involving medical imaging modalities. Responsibilities include developing imaging protocols, supervising data acquisition, and interpreting complex results to support clinical decision-making.
The role involves forecasting and managing vendor-related costs for clinical trials using large datasets from procurement and contract databases. Key duties include performing budget reconciliations, leading alignment meetings with vendors, and monitoring the overall financial health of studies.
Oversee the planning and execution of clinical supplies projects to ensure timely delivery and regulatory compliance. Collaborate with cross-functional teams to optimize budgets, resource allocations, and logistics strategies.
The Site Payment Analyst manages site payments and subject reimbursements for assigned clinical studies according to agreements and regulations. They collaborate with vendors to configure payment systems and perform quality control reviews to ensure timely and accurate processing.
Responsible for the creation, oversight, and management of investigator site budgets and contracts for multiple clinical trials. This includes leveraging FMV benchmarking tools and managing CRO negotiations to ensure consistency across programs.
The manager is responsible for evaluating, validating, and maintaining Digital Health data capture systems to support clinical trial activities. This includes leading project workstreams, documenting complex business requirements, and managing the DH governance framework.
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.
The role involves coordinating the setup and monitoring of clinical trials while maintaining accurate study documentation and status reports. It also requires managing stakeholder relationships and ensuring patient safety through strict adherence to protocols and 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 to ensure accurate data collection.
Lead biostatistics tasks for clinical studies, including the development of statistical analysis plans and reporting specifications. Perform statistical analyses and interpret complex medical data to advance innovative treatments.
Provide strategic oversight and execution of clinical data management activities across one or more clinical trials. Ensure high standards of data integrity, quality, and regulatory compliance while collaborating with global cross-functional stakeholders.
Manage clinical trial operations activities, including budget oversight and study start-up, to deliver high-quality outcomes. Coordinate trial delivery, resolve operational issues, and mentor Clinical Research Associates to optimize performance.
The CRA II is responsible for conducting site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. They also perform data review and collaborate 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 strong relationships with investigators and ensuring patient safety through regulatory compliance.
The role involves conducting site qualification, initiation, monitoring, and close-out visits to ensure clinical trials align with protocols and regulatory standards. Key duties include maintaining data integrity, ensuring patient safety, and collaborating with investigators to facilitate smooth study conduct.
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.
Manage the full lifecycle of COA licensing projects from qualification and proposal development to final delivery. Serve as the primary point of contact for client accounts, ensuring satisfaction and identifying opportunities for engagement expansion.
Perform 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 clinical sites while maintaining inspection readiness.
Lead the planning, implementation, and management of cross-functional eCOA projects, including scope definition and resource allocation. Monitor project progress, manage budgets and quality issues, and report results to stakeholders.
Manage clinical trial operations activities with a focus on coordinating delivery, resolving issues, and developing team capability. Key duties include budget oversight, monitoring plan development, and fostering relationships with sponsors and vendors.
Lead the initiation of clinical trials by preparing and submitting regulatory documents and coordinating with stakeholders for study approvals. Maintain accurate records of submissions and provide guidance to study teams on regulatory best practices.
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.
Generate new and repeat business opportunities within the Pharmaceutical, Biotechnology, and Medical Device industries. Promote Phase II-III services and build long-term strategic partnerships to drive growth in the assigned territory.
Manage biospecimen projects within a global healthcare intelligence and clinical research organization. Coordinate the delivery of new medicines and medical devices to patients worldwide.
Manage biospecimen projects within a global healthcare intelligence and clinical research organization. Coordinate the delivery of new medicines and medical devices to patients worldwide.
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.
Coordinate the setup and monitoring of oncology clinical trials while ensuring patient safety and regulatory compliance. Maintain strong relationships with clinical investigators and manage study documentation and cost efficiency.
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.
The role involves strategizing and overseeing patient recruitment initiatives for clinical trials to ensure quality and timeline expectations are met. Key duties include leading cross-functional teams, building partnerships with healthcare providers, and analyzing recruitment metrics to optimize performance.
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.
Develop, validate, and maintain complex statistical programs for data manipulation and reporting in clinical trials and real-world evidence studies. Collaborate with biostatisticians to implement statistical analyses and ensure compliance with regulatory standards.
The role involves coordinating monitoring activities at clinical trial sites to ensure compliance with study protocols and GCP guidelines. Key duties include preparing regulatory documents, tracking site performance metrics, and collaborating with cross-functional teams.
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 manage projects to ensure successful execution and delivery of objectives within a global healthcare intelligence organization. Responsibilities include developing project plans, leading cross-functional teams, and mentoring staff to foster a culture of excellence.
The Senior CRA is responsible for managing investigative sites and performing monitoring visits to ensure data integrity and subject safety in Oncology clinical trials. This includes facilitating communication between the client and sites, managing essential documents, and ensuring inspection readiness.
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 involves coordinating monitoring activities at clinical trial sites to ensure compliance with study protocols and GCP guidelines. Responsibilities include preparing regulatory documents, tracking site performance metrics, and collaborating with cross-functional teams.
Lead the design and implementation of data science strategies to enhance clinical trial data analysis and optimize data interpretation. Manage day-to-day activities, mentor team members, and communicate actionable insights to stakeholders to influence project direction.
Develop and validate statistical programming code to support data analysis and reporting for clinical trials. Act as a technical expert and key contact for stakeholders to deliver high-quality clinical data science solutions.
The Informed Consent Writer is responsible for preparing and editing clinical trial consent documents using health-literate language for lay audiences. They collaborate with protocol authors and clinical teams to ensure documentation is accurate, compliant with regulations, and delivered on time.
The role involves conducting site qualification, initiation, monitoring, and close-out visits to ensure protocol compliance and patient safety. Responsibilities also include performing data review and collaborating with investigators to maintain high-quality clinical data.
Oversee and drive the end-to-end site activation process for clinical trials, including site identification and regulatory submissions. Collaborate with cross-functional teams to ensure milestones are met and provide mentorship to junior team members.
The role involves reviewing, analyzing, and negotiating contracts and legal documents related to clinical trials and vendor relationships. The manager will collaborate with cross-functional teams to mitigate risks and maintain accurate records within contract management systems.
The role involves conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. It also requires ensuring protocol compliance and collaborating with pharmacy teams to maintain high-quality unblinded clinical data.
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.
Serve as the primary contact between investigational sites and sponsors while conducting various site visits to ensure compliance with ICH-GCP and regulations. Responsibilities include monitoring patient safety, overseeing drug accountability, and managing data quality and site 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.
Provide medical and scientific oversight for early phase clinical trials to ensure subject safety and data integrity. Collaborate with cross-functional teams to design protocols and interpret clinical data to guide development strategies.
Manage the end-to-end contract lifecycle for research, including drafting, negotiating, and executing complex agreements. Collaborate with legal, compliance, and internal stakeholders to develop playbooks and improve contract management processes.
Support the design, implementation, and management of clinical trials by coordinating site initiation and patient recruitment. Ensure adherence to protocols and regulatory guidelines while maintaining comprehensive study documentation and collaborating with cross-functional teams.
Lead and manage projects to ensure successful execution and delivery of objectives within a healthcare intelligence environment. Responsibilities include developing project plans, leading cross-functional teams, and mentoring staff to foster a culture of excellence.
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 contractual records.
Manage all vendor-related aspects of global clinical trials, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams to implement protocols and maintain relationships with trial investigators and stakeholders.
Manage day-to-day clinical trial operations and lead RBM strategy meetings to develop site monitoring plans. Oversee site monitoring compliance, review visit reports, and partner with RBQM operations to ensure high-quality clinical outcomes.
Design and conduct clinical studies to evaluate the safety and efficacy of innovative treatments, focusing on protocol development and regulatory documentation. Perform high-quality clinical data review and provide insights to improve data integrity and subject safety throughout the study lifecycle.
Lead medical affairs delivery and provide strategic medical leadership across a portfolio of project teams. Ensure compliance with ethical and regulatory standards while offering expert scientific guidance throughout project lifecycles.
The Senior Clinical Scientist is responsible for designing and conducting clinical studies, including the development of protocols and key regulatory documents. They perform high-quality clinical data reviews to identify insights and ensure subject safety and data integrity throughout the study lifecycle.
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.
Design, develop, and implement Clinical Outcome Assessment (COA) training and certification programs for clinical studies. Lead training delivery to sites and investigators while providing consultancy on data collection quality and rater eligibility.
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 Consultant - Systematic Reviews & Evidence Synthesis
ICON plc
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Full Time
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19 days ago
ICON plc
Act as project director managing systematic literature reviews and evidence synthesis to ensure high-quality deliverables for pharmaceutical and medical device clients. Lead business development, proposal creation, and provide technical mentorship and managerial oversight to the global team.
The consultant supports operational staff in using ADaM and define.xml for statistical analysis within Medidata standards. They are responsible for developing efficiency tools, managing metadata repositories, and consulting with clients on CDISC implementation projects.
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.
Manage client relationships by providing quotes and delivering clinical outcome assessment (COA) licensing and translation services. Oversee the project lifecycle from proposal to delivery while mentoring junior staff and managing key strategic accounts.
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 manage clinical projects focusing on radiopharmaceutical and radioligand-based oncology programs. Responsibilities include developing project plans, leading cross-functional teams, and managing stakeholder requirements to ensure quality outcomes.
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 filings and negotiating with health authorities like the FDA to ensure submission approval.
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 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 facilitate smooth trial execution.
Oversee the contracting process and manage day-to-day supply chain and procurement activities to ensure cost-effective sourcing. Lead a team of contract analysts and maintain department metrics and trackers to ensure compliance with company standards.
Manage global pharmacovigilance activities for late-stage clinical development and commercial launch of oncology products. Ensure compliance with global safety regulations through ICSR processing, safety reporting, and cross-functional collaboration.
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 Clinical Operations Lead supports the execution of clinical trials by managing CROs, ancillary vendors, and study timelines. Responsibilities include developing clinical trial documents, coordinating site activities, and collaborating with multi-disciplinary teams to ensure trial quality.
The Senior Clinical Trial Manager is responsible for the operational implementation of clinical trials, managing timelines, budgets, and site selection. They serve as the primary liaison for internal stakeholders and vendors to ensure trials are delivered on time and with high quality.
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.
Senior Clinical Trial Manager and Clinical Trial Manager
ICON plc
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Full Time
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19 days ago
ICON plc
Responsible for the end-to-end operational oversight of clinical trials, ensuring delivery against timelines, budget, and quality standards. This includes managing site lifecycles, leading clinical teams, and maintaining stakeholder relationships.
Responsible for the end-to-end operational oversight of clinical trials, ensuring delivery against timelines, budget, and quality standards. This includes managing site lifecycles, leading clinical teams, and maintaining sponsor relationships.
Develop and implement comprehensive risk management strategies to ensure the safety and integrity of clinical trials. Lead the identification, assessment, and mitigation of risks while managing day-to-day scientific operations and training staff.
Coordinate and monitor clinical trial activities, including study setup, status reporting, and documentation maintenance. Build collaborative relationships with investigators and site staff while ensuring strict compliance with regulatory requirements and patient safety.
The Clinical Trial Manager provides end-to-end operational oversight of clinical trials to ensure delivery within timelines, budget, and quality standards. This includes leading clinical teams, managing site lifecycles, and collaborating with cross-functional stakeholders and sponsors.
The Senior Clinical Trial Manager provides end-to-end operational oversight of assigned clinical trials to ensure delivery within timelines, budget, and quality standards. This includes leading clinical teams, managing site lifecycles, and maintaining strong relationships with sponsors and cross-functional teams.
Lead and oversee clinical data programming activities across multiple trials to ensure quality and regulatory compliance. Coordinate data analysis delivery, develop programming strategies, and mentor team members to enhance overall capability.
The Senior Biostatistician will lead the design and analysis of clinical trials, focusing on developing statistical analysis plans and reporting specifications. They are responsible for interpreting complex medical data and managing statistical aspects of CRF design and randomization.
The role serves as a bridge between Clinical Development, Medical Affairs, and commercial organizations for solid tumor products. Key duties include developing medical communication strategies, managing educational materials, and acting as the medical point of contact for clinical studies.
Lead the development of high-quality regulatory and clinical documents to support submissions to regulatory authorities. Coordinate writing assignments, formulate strategies, and ensure compliance with industry standards and sponsor requirements.
The lead drives data-driven feasibility and site strategies to optimize clinical study delivery and enrollment projections. They partner cross-functionally to provide strategic recommendations on country footprint and protocol optimization using real-world data.
Lead the negotiation of clinical trial agreements and budgets with investigator sites to ensure timely and compliant outcomes. Collaborate with legal, finance, and project teams to align contract terms with sponsor requirements and internal policies.
Lead biostatistics tasks for multiple clinical studies, focusing on the design and analysis of complex medical data. Act as a functional lead and resource for less experienced colleagues to achieve operational and strategic goals.
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 supporting the execution and management of clinical trials by handling monitoring deliverables and ensuring quality and efficiency. Key tasks include conducting site feasibility assessments, coordinating with investigative sites, and monitoring data collection activities.
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.
The role involves coordinating and monitoring clinical trial activities, ensuring accurate study status reports and documentation. It also requires maintaining strong relationships with investigators and ensuring patient safety through regulatory compliance.
The Grants Specialist manages the end-to-end grant application process, including identifying opportunities and developing compelling proposals. They are also responsible for ensuring compliance with funding requirements and reporting on grant outcomes.
The role involves designing and implementing clinical trial enrollment strategies while analyzing complex medical data for accuracy and compliance. The liaison acts as a primary point of contact between sponsors, investigators, and participants to optimize trial outcomes.
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 in compliance with international regulations.
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.
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 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.
Oncology Scientific Lead, Med Com (Associate Scientific Dir)
ICON plc
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Full Time
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21 days 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.
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.
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.
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.
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.
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 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.
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.
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 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.
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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24 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.
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.
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.
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.
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.
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.
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.
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 provide guidance to site staff and other CRAs.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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 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.
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.
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.
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.
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.
Clinical Research Associate II or 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.
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 clinical trial conduct.
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.
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.
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.
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.
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.
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 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, 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.
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.
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 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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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 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 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.
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.
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.
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.
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.
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 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.
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 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.
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 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.
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.
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.
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.
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.
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.
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 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 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.
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 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 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.
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.
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 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.
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.
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.
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.
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.
Clinical Research Associate II/Senior Clinical Research Associate
ICON plc
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Full Time
·
2 months 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 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.
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 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.
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.
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 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 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.
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 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 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 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.
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 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.
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 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 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.
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 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 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 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.
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 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.
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.
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.
