The Patient Recruitment Manager is responsible for developing and executing patient recruitment and retention strategies for clinical studies. They manage vendor relationships, oversee study budgets, and ensure compliance while serving as the primary point of contact for project teams and clients.
Responsible for all aspects of clinical study site monitoring, including routine visits, site management, and ensuring protocol adherence. Manages data integrity, regulatory compliance, and site-level audit readiness while coordinating with vendors and internal teams.
The Clinical Research Associate is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage data integrity, process Serious Adverse Event reports, and coordinate clinical projects as a local contact.
The CRA 2 is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage data integrity, serious adverse event reporting, and coordinate clinical projects as a local contact.
The role involves managing all aspects of study site monitoring, including routine visits, site initiation, and close-out procedures. You will also ensure data integrity, oversee patient safety, and manage serious adverse event reporting according to regulatory requirements.
The Clinical Data Specialist is responsible for conducting clinical data review, query management, and reconciliation to ensure data integrity and project timelines. They also assist in the development of data management plans and support the setup, maintenance, and closure of clinical data management systems.
The Associate Clinical Data Manager leads end-to-end data management activities for clinical studies, ensuring quality, timelines, and budget adherence. They provide leadership to the study team, manage sponsor requirements, and coordinate with cross-functional departments to achieve database lock.
The specialist will negotiate and manage site agreements, confidentiality agreements, and other clinical trial contracts while ensuring regulatory compliance. They will also collaborate with internal teams and maintain accurate contract documentation to support clinical research efforts.
The Clinical Trial Manager oversees the end-to-end delivery of clinical research trials, managing project scope, timelines, and budgets from site identification to database lock. They ensure quality and regulatory compliance while leading site activation, recruitment strategies, and cross-functional team collaboration.
Develops and delivers reimbursement and health economics services while serving as a strategic consultant for Fortrea clients. Leads business development efforts, manages client relationships, and provides leadership to staff to ensure high-quality project delivery.
You will support the management of clinical trial sites by conducting monitoring visits and ensuring compliance with ICH-GCP and study protocols. Additionally, you will perform source data verification and assist cross-functional teams in resolving site-related issues to maintain data quality.
The Executive Director will lead therapeutic strategy and business development across the APAC region, fostering high-level client relationships and driving scientific initiatives. They will also provide leadership, mentoring, and strategic direction to medical and operations teams to ensure high-quality trial delivery.
The Senior Site Navigator coordinates site-level activities during clinical study start-up, maintenance, and closeout phases. They act as the primary point of contact for investigative sites, ensuring regulatory compliance and effective collaboration between sponsors and site staff.
The associate supports the supplier qualification process by conducting quality risk assessments and maintaining the Qualified Supplier List. They also coordinate with internal SMEs and the wider QA team to ensure compliance and audit readiness for clinical suppliers.
The specialist will negotiate and manage site agreements, confidentiality agreements, and other clinical trial contracts while ensuring regulatory compliance. They will also collaborate with internal teams and maintain accurate contract documentation to support clinical research efforts.
The Clinical Trial Manager II oversees the end-to-end delivery of clinical research trials, including site identification, start-up activities, and database lock. They are responsible for managing project scope, timelines, budgets, and ensuring compliance with regulatory requirements and quality standards.
Lead the development and support of clinical technology solutions while designing and validating complex SAS programs and datasets. Collaborate with global teams to drive data quality, automation, and the creation of impactful visual analytics dashboards.
The associate will assist with safety system implementation, configuration, and migration activities while providing support for internal and external clients. Responsibilities include managing system tickets, performing data extraction, conducting user acceptance testing, and training team members on technical and functional aspects.
The Senior Associate is responsible for supporting Real-world Evidence services by delivering complex analyses of data from global observational studies and secondary sources. They will develop analysis-ready datasets, create tables, figures, and listings, and provide programming support to biostatisticians and epidemiologists.
The PSS Associate is responsible for processing adverse event reports from clinical trials and post-marketing sources to ensure regulatory compliance. They also manage safety databases, write patient narratives, and coordinate the submission of expedited safety reports to regulatory authorities.
Provide leadership for clinical data management projects, including oversight of vendor performance, budgets, and strategic planning. Act as the primary point of contact for clinical data management while ensuring compliance with industry standards and study protocols.
The Senior Clinical Data Manager leads end-to-end data management activities for clinical studies, ensuring quality, timelines, and budget adherence. They provide mentorship to junior staff, manage sponsor relationships, and oversee the implementation of study-specific data processes.
The Director/Senior Director leads the strategic development and execution of participant recruitment, engagement, and retention initiatives for clinical trials. This role involves managing multi-channel marketing campaigns, analyzing recruitment metrics, and building high-performing teams to meet enrollment objectives.
The Clinical Trial Manager is responsible for the clinical delivery of research trials, ensuring they meet contractual, budgetary, and regulatory requirements. They lead project teams, manage clinical site operations, and proactively identify and mitigate project risks.
The Senior Clinical Research Associate II is responsible for site monitoring, site management, and ensuring adherence to study protocols and regulatory guidelines. They also act as a lead monitor, mentor junior staff, and coordinate clinical projects while maintaining data integrity.
Lead local laboratory data management activities across assigned studies, ensuring high-quality delivery and compliance with regulatory standards. Oversee vendor interactions and collaborate with cross-functional teams to align lab data strategies with study requirements.
The Site Navigator oversees site-level activities during clinical study start-up, ensuring regulatory compliance and effective site management. They serve as the primary point of contact for investigative sites, managing outreach, contract negotiations, and document quality reviews.
The role involves preparing, compiling, and reviewing regulatory and CMC documentation to support global product registrations and life cycle maintenance. Additionally, the assistant will coordinate with cross-functional teams to manage change controls, labeling projects, and ensure compliance with regulatory guidelines.
The Costing Manager supports the Costing Department by managing clinical study costings, reviewing RFP scopes, and ensuring alignment with customized delivery strategies. They also coordinate with cross-functional stakeholders to finalize budgets, manage vendor costs, and contribute to strategic process improvements.
You will be responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. Additionally, you will ensure patient safety, data integrity, and adherence to protocol requirements across clinical trial sites.
The role involves responding to medical information queries and product quality complaints via telephone, email, and fax. Additionally, the assistant will record and report adverse drug reactions while performing data tracking and quality control tasks.
Responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. Ensures patient protection, protocol adherence, and data integrity through careful source document review and site management.
The Clinical Research Associate is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage data integrity, handle serious adverse event reporting, and coordinate clinical projects as a local contact.
The Executive Director defines and executes the clinical platforms product strategy while leading end-to-end product development and operational delivery. They act as a primary integrator across clinical, commercial, and regulatory functions to ensure platform capabilities align with business objectives and sponsor expectations.
The Senior Statistical Programmer will lead programming activities for clinical studies, including resource estimation, budget management, and timeline adherence. They are responsible for developing SAS programs for SDTM and ADaM datasets, performing quality control, and mentoring less-experienced team members.
The Proposal Manager I leads the end-to-end proposal process, including text, budget, and response development for FSP opportunities. They collaborate across a matrix organization to ensure high-quality, competitive deliverables that meet client requirements and business objectives.
The CRA 2 is responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and ensuring protocol adherence. They also manage site documentation, data integrity, and serious adverse event reporting while coordinating clinical projects.
The role involves developing and maintaining investigator grant forecasts across the global clinical development portfolio to ensure accurate financial planning. You will partner with cross-functional teams to reconcile forecasts, explain variances, and support executive reporting through data-driven insights.
The Senior Director is responsible for defining the strategy, roadmap, and lifecycle management of Fortrea's commercial and marketing technology platforms. They will lead a high-performing team to deliver scalable technology solutions that drive business growth, operational efficiency, and data-driven decision-making.
The Aggregate Report Specialist supports the preparation, review, and coordination of pharmacovigilance deliverables such as PBRERs and PADERs. They also collaborate with cross-functional stakeholders, conduct data analysis, and mentor junior team members to ensure high-quality, timely report execution.
The Clinical Team Lead owns the clinical delivery of research trials, functioning as the project manager to ensure successful execution within contractual and budgetary requirements. They drive project performance, manage clinical strategy, oversee site monitoring, and lead high-performing teams in a matrixed environment.
The Clinical Research Associate is responsible for all aspects of study site monitoring, including routine visits, site management, and maintenance of study files. They ensure protocol adherence, data integrity, and the protection of study participants while managing serious adverse event reporting.
The Clinical Trial Administrator supports the clinical project team by maintaining study documentation, tracking activities, and managing Trial Master File records. They also coordinate study supply shipments, assist with investigator meetings, and ensure compliance with regulatory standards and SOPs.
The CRA 2 is responsible for all aspects of study site monitoring, including routine monitoring, site management, and ensuring protocol adherence. They also manage registry tasks, process Serious Adverse Event reports, and maintain data integrity within electronic systems.
The Regulatory Assistant II is responsible for the creation, revision, and compilation of regulatory documents for global health authority submissions. They also coordinate cross-functional teams to manage product changes, labeling projects, and quality specifications.
The Senior Architect will design and maintain the organization's IT architecture framework while providing strategic technical leadership to development teams. They are responsible for translating business requirements into scalable end-to-end IT solutions and ensuring alignment with industry best practices.
The Labeling Operations Specialist manages the creation and update of labeling documents while ensuring compliance with regulatory requirements and internal SOPs. They facilitate document workflows, coordinate with stakeholders, and maintain labeling tracking systems to ensure project timelines are met.
Lead statistical strategy and delivery for complex clinical trials, ensuring high-quality outputs and regulatory compliance. Provide technical leadership, mentor junior staff, and collaborate with multidisciplinary stakeholders to support global programs.
Organize and manage all necessary submissions and applications to ethics committees and authorities in Germany. Coordinate local start-up processes, including vendor management and the adaptation of global study documents.
Conduct and oversee study site monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements. Manage all aspects of site activities including initiation, routine monitoring, and closeout while ensuring patient safety and data integrity.
The Study Start Up Manager will oversee clinical trial site identification and activation activities while managing regulatory submissions and timelines. They will collaborate with cross-functional teams and external vendors to ensure operational excellence and compliance with global standards.
The Compensation Specialist will support compensation reporting, analytics, and market pricing activities across the EMEA region. They will also assist with pay transparency initiatives, compliance, and compensation review cycles.
The Senior Architect will design and maintain enterprise IT architecture, focusing on data governance, MDM, and AI-enabled data management platforms. They will lead technical design, mentor junior staff, and translate complex business requirements into scalable technical solutions.
The Site Navigator II coordinates site-level activities during the clinical study start-up phase, serving as the primary point of contact for investigative sites. They ensure regulatory compliance, manage site activation tasks, and facilitate effective communication between sponsors, CROs, and clinical staff.
The Senior Clinical Data Manager leads end-to-end data management activities for clinical studies, ensuring compliance with protocols, budgets, and timelines. They also provide mentorship to junior staff, manage sponsor relationships, and drive process improvements within the Biometrics department.
The Senior Clinical Research Associate is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage data integrity, serious adverse event reporting, and provide support for clinical project coordination.
The Unblinded CRA will perform monitoring activities, ensure protocol compliance, and maintain study documentation in accordance with ICH-GCP guidelines. They will also act as the primary point of contact for pharmacy site staff and contribute to audit and inspection readiness.
The Business Development Director is responsible for achieving annual sales targets, managing client relationships, and developing account plans for assigned accounts. They will lead client presentations, manage the sales pipeline in Salesforce, and collaborate with internal units to identify and win multi-unit projects.
You will act as a support voice for healthcare professionals and patients by managing medical information queries and product quality complaints. Additionally, you will record and report Adverse Drug Reactions in strict compliance with regulatory standards and internal SOPs.
The Clinical Team Lead manages the clinical delivery of research trials, overseeing project strategy, timelines, quality, and budget. They lead cross-functional teams, drive site management, and ensure adherence to regulatory requirements and client expectations.
The RFI Associate manages end-to-end RFI opportunities by reviewing requirements, drafting content, and collaborating with SMEs to meet deadlines. They also support senior colleagues with complex opportunities, perform quality control, and contribute to the departmental content library.
The Start-up Associate serves as the primary contact for investigative sites, managing regulatory document collection and submission processes to ensure site readiness. They also support study maintenance activities, track project progress, and ensure compliance with ICH/GCP guidelines and local regulations.
The Start-up Specialist acts as the primary contact for investigative sites, managing the collection of essential documents and ensuring regulatory compliance for study start-up. They also coordinate submissions to regulatory authorities and ethics committees while mentoring less-experienced team members.
The Statistical Programmer II will lead programming activities for clinical trials, including resource estimation and budget management. They are responsible for developing and maintaining SAS programs to create SDTM and ADaM datasets while ensuring high-quality deliverables.
The FSP Solutions Consultant serves as a strategic partner to drive new business opportunities and manage long-term client relationships. They collaborate with internal teams to develop proposals, manage sales pipelines, and provide subject matter expertise to ensure client satisfaction.
The role involves leading the end-to-end development of high-complexity clinical regulatory documents, including protocols, clinical study reports, and regulatory briefing packages. You will coordinate cross-functional teams and manage the document review process to ensure alignment with project strategy and timelines.
Manage clinical trial sites by performing monitoring visits and ensuring adherence to protocols, ICH GCP, and Fortrea SOPs. Maintain data integrity, oversee investigational product handling, and ensure site regulatory documentation is accurate and audit-ready.
You will lead eCRF design and database programming within the Medidata Rave EDC system for assigned clinical projects. Additionally, you will be responsible for developing edit check specifications, performing quality control, and providing guidance to team members.
Conduct and oversee study site monitoring visits to ensure compliance with protocols, regulatory requirements, and GCP guidelines. Manage all aspects of site activities including initiation, monitoring, closeouts, and the tracking of Serious Adverse Events.
The Site Navigator I manages clinical trial start-up activities, including site identification, regulatory document coordination, and contract negotiations. They also perform in-house CRA responsibilities such as data validation, CRF review, and remote monitoring tasks.
Conduct national monitoring across the UK for a diverse range of therapeutic areas including oncology and ophthalmology. Manage clinical trials using a risk-based monitoring model to ensure efficient trial oversight.
The Site Start-Up Specialist coordinates site start-up activities, manages essential regulatory documents, and ensures compliance with ICH/GCP guidelines. They serve as the primary contact for investigative sites and collaborate with stakeholders to ensure audit-ready documentation.
The Senior Clinical Project Manager will lead end-to-end delivery of clinical pharmacology projects, overseeing complex studies and managing global cross-functional teams. They are responsible for maintaining project scope, timelines, and budgets while ensuring compliance with regulatory standards and building strong client relationships.
The Senior Coding Specialist will oversee outsourced medical coding activities and ensure the quality and consistency of clinical trial data. They will also serve as a subject matter expert for dictionary usage and support upversioning across global studies.
The Clinical Project Manager is responsible for driving project performance, managing budgets, and ensuring adherence to timelines and quality standards throughout the clinical trial lifecycle. They will lead cross-functional teams, manage client relationships, and implement risk management strategies to ensure successful project delivery.
The Centralized Clinical Team Lead II manages complex clinical projects, ensuring site monitoring activities comply with SOPs, ICH guidelines, and GCP standards. They act as a primary point of contact for global teams, identifying risks, mentoring staff, and leading process improvement initiatives.
Conduct study site monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements. Manage the full site lifecycle from initiation to closeout while supporting patient safety and data integrity.
The Site Navigator II coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Key duties include managing regulatory compliance, performing site selection, and negotiating contracts and budgets to ensure efficient site activation.
Lead and oversee site budget and contract activities across assigned countries to ensure timely clinical trial start-up. Negotiate Clinical Trial Agreements (CTAs) and manage budgets while acting as an escalation point for complex discussions.
The Site SSU Lead is responsible for leading site activation teams and shaping study start-up strategies to ensure clinical trials are ready to enroll participants on time. This includes developing country-specific Informed Consent Forms and using data-driven insights to optimize performance and timelines.
Lead and support site activation teams to ensure clinical studies are activated efficiently and ready to enroll participants on time. Partner with Clinical Operations to improve timelines and develop country-specific Informed Consent Forms.
Lead and oversee site budget and contract activities across assigned countries to ensure timely clinical trial start-up. Negotiate Clinical Trial Agreements (CTAs) and manage budgets while collaborating with study teams and sponsors.
The specialist coordinates site start-up activities and manages essential regulatory documents for clinical trials. They serve as the primary contact for investigative sites and ensure compliance with ICH/GCP guidelines and sponsor specifications.
Lead and empower site activation teams to drive the successful planning and activation of global clinical trials. Develop data-driven forecasting models and optimize study start-up metrics to accelerate study timelines.
Negotiate and manage site agreements, confidentiality agreements, and letters of indemnification for clinical trials. Ensure compliance with SOPs and regulatory guidelines while collaborating with legal and project management teams.
Coordinate site start-up activities and manage essential regulatory documents for clinical trials. Serve as the primary contact for investigative sites to ensure compliance with ICH/GCP guidelines and sponsor specifications.
Lead and empower site activation teams to drive the successful planning and activation of clinical trials across multiple countries. Manage EU-CTR submissions, document oversight, and the development of new study start-up processes and SOPs.
Lead and mentor site activation teams to drive the successful planning and activation of global clinical trials. Partner with Clinical Operations to optimize study start-up metrics and implement data-driven forecasting models.
Responsible for all aspects of clinical site monitoring, including routine visits, close-outs, and site management. Ensures data integrity, patient protection, and adherence to study protocols and regulatory requirements.
Responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. Ensures the protection of study patients and the integrity of data submitted on Case Report Forms.
The role involves acting as the primary contact for clinical trial sites and managing the site lifecycle from start-up to close-out. Responsibilities include conducting monitoring visits and ensuring compliance with study protocols and regulatory requirements.
Develop and manage Investigator Grant Estimates and detailed study budgets for clinical trial proposals. Partner with stakeholders to create competitive costing strategies and drive process improvements in grants management.
Responsible for all aspects of clinical site monitoring, including initiation, routine visits, and close-out of oncology trials. Ensures data integrity, patient safety, and adherence to study protocols and regulatory requirements.
Responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and site management. Ensures the protection of study participants and the integrity of clinical trial data through rigorous verification and reporting.
Responsible for site management and monitoring of clinical trials, including conducting initiation, routine, and close-out visits. Ensures data integrity, subject protection, and adherence to ICH GCP guidelines and sponsor requirements.
Responsible for clinical site monitoring, management, and ensuring adherence to regulatory guidelines and project plans. Acts as a leader for limited-scope projects and coordinates local project activities including site initiation and closeout.
Lead the design, governance, and enhancement of the Workday security framework to ensure secure and compliant access to enterprise data. Partner with HR, Finance, and IT teams to manage security policies, conduct audits, and resolve security-related incidents.
Support the acquisition, review, and integration of external clinical trial data to ensure integrity and quality. Coordinate with internal teams and external vendors to resolve data discrepancies and meet study deliverables.
Serve as a subject matter expert in Real World Data analytics to support the analysis of large healthcare databases for pharmaceutical compounds. Collaborate with cross-functional stakeholders to contribute to study design, programming, and the interpretation of study results.
Drive revenue growth by managing strategic biotech accounts and cultivating relationships with key decision-makers. Lead the development of account plans, pricing, and proposals while collaborating across business units to identify multi-unit opportunities.
Oversee site, regional, and study-level centralized and risk-based monitoring activities to identify risks and ensure timely resolution. Partner with clinical leads and sponsors to drive risk assessments, analytics, and compliance with regulatory requirements.
Lead the overall product lifecycle and strategy for clinical data management software within the life sciences sector. Bridge the gap between technology and business to deliver innovative, compliant products that meet client needs and strategic goals.
Responsible for managing the end-to-end processing of adverse event reports from clinical trials and post-marketing settings. This includes data entry, MedDRA coding, writing patient narratives, and ensuring timely submission of expedited reports to regulatory agencies.
Responsible for site management and monitoring of clinical trials, including conducting initiation, routine, and close-out visits. Ensures subject protection, data integrity, and adherence to ICH GCP guidelines and sponsor requirements.
The role involves building and maintaining clinical study site budgets and negotiating rate cards for clinical trial agreements. You will partner with internal teams and site payment departments to ensure compatibility with payment systems and EDC requirements.
Lead the full cycle of Clinical Data Management for oncology studies, serving as the primary point of contact for sponsors. Responsibilities include creating eCRFs, cleaning data, and managing vendor contracts and budgets.
The Senior Project Manager oversees domestic and global clinical projects, managing scope, cost, quality, and stakeholder expectations. They are also responsible for leading project teams, ensuring regulatory data accuracy, and potentially handling line management and business development.
Provide medical safety expertise for clinical trials and post-marketing periods, including the medical review of adverse events. Responsible for preparing aggregate reports and performing signal detection and evaluation for global regulatory agencies.
The role involves negotiating and managing site agreements, budgets, and confidentiality contracts for clinical research studies. It also requires partnering with internal teams to improve budget metrics and ensure compatibility with payment systems.
Coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Ensures regulatory compliance, manages site activation, and handles contract and budget negotiations.
Support the delivery and logistics of clinical and ancillary supplies for assigned studies, including label review and country translations. Coordinate importation processes, manage vendor activities, and liaise with project teams to ensure smooth supply transportation.
The Site Start-Up Specialist coordinates site activation activities and manages essential regulatory documents for clinical trials. They serve as the primary contact for investigative sites to ensure compliance with ICH/GCP guidelines and sponsor specifications.
The specialist is responsible for preparing, negotiating, and managing site agreements and confidentiality agreements for clinical trials. They ensure compliance with SOPs and regulatory guidelines while collaborating with legal and project management teams.
The role involves executing change management activities and translating strategies into practical delivery plans for Clinical Data Management transformation initiatives. Key duties include stakeholder mapping, coordinating engagement activities, and monitoring change adoption outcomes.
Responsible for comprehensive site monitoring and management of complex cardiac and medical device clinical studies. This includes conducting initiation and closeout visits, ensuring data integrity, and overseeing regulatory compliance at the site level.
The Clinical Team Lead owns the clinical delivery of research trials, functioning as the Clinical Project Manager within the core project team. They are responsible for managing project scope, timelines, budgets, and site management while ensuring operational excellence and client satisfaction.
Manage the planning, execution, and completion of oncology clinical trials while ensuring timelines, budgets, and quality standards are met. Serve as the primary contact for clinical operations teams and vendors while ensuring compliance with German EU regulatory requirements.
Act as the primary contact for clinical trial sites, managing the full site lifecycle from start-up to close-out. Ensure study compliance with ICH-GCP and local regulations while overseeing data quality and site performance.
Manage all aspects of site management from selection to close-out for complex Phase I-III clinical trials. Provide support through training and mentoring new employees and act as a subject matter expert in customer-specific working groups.
Provide executive leadership for Quality Assurance and Regulatory Compliance within the Clinical Pharmacology Services business unit. Lead the design and implementation of audit, inspection readiness, and quality oversight programs across global clinical pharmacology units and GMP pharmacies.
Provide executive leadership for Quality Assurance and Regulatory Compliance within the Clinical Pharmacology Services business unit. Lead the design and implementation of audit and inspection readiness programs across global clinical pharmacology units and GMP pharmacies.
The Senior CRA is responsible for comprehensive site monitoring and management, ensuring clinical studies adhere to SOPs and regulatory guidelines. Key duties include conducting initiation and closeout visits, managing study files, and overseeing data integrity and patient safety.
The role involves designing, configuring, and deploying Workday Procure-to-Pay solutions to optimize procurement and payment processes globally. The manager will partner with Finance and Procurement teams to deliver scalable solutions and manage system updates during Workday releases.
Manage clinical trial start-up activities, including site identification, feasibility, and regulatory submissions to Ethics Committees and Regulatory Authorities. Perform in-house CRA tasks such as document review, data validation, and TMF maintenance to ensure inspection readiness.
Responsible for all aspects of study site monitoring, including routine visits, close-outs, and site management for oncology clinical trials. Ensures data integrity, patient protection, and adherence to protocol and regulatory requirements.
Responsible for all aspects of clinical site monitoring, including routine visits, close-outs, and site management. Ensures patient protection, data integrity, and adherence to study protocols and regulatory requirements.
Lead the end-to-end delivery of Healthy Volunteers and Patient Clinical Pharmacology projects, managing scope, timelines, and budgets. Act as the primary contact for sponsors while ensuring quality, compliance, and adherence to ICH/GCP standards.
Lead and oversee site start-up and activation activities while serving as the primary contact for investigative sites. Manage regulatory submissions, contract negotiations, and mentor junior Site Navigators to ensure study efficiency and compliance.
Design and implement statistical strategies and analysis plans for clinical trials across various therapeutic areas. Perform SAS programming to generate study reports and provide expert guidance on methodology and sample size calculations.
Conduct site monitoring visits and ensure compliance with protocols, SOPs, and regulations. Perform source data verification and manage SAE reporting to ensure patient safety and data quality.
Coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Ensures regulatory compliance, manages site activation milestones, and handles contract and budget negotiations.
Lead and manage clinical sites across complex indications while building relationships with investigators. Ensure patient safety and data integrity are maintained throughout innovative first-in-class studies.
Prepares, negotiates, and executes site agreements and confidentiality contracts for sponsors. Maintains contract tracking systems and ensures all activities comply with departmental SOPs and corporate requirements.
Support the management of clinical trial sites by conducting monitoring visits and ensuring compliance with SOPs and ICH-GCP guidelines. Perform source data verification and maintain essential trial documentation to ensure data quality and inspection readiness.
The Contract Analyst II will independently develop, review, and negotiate medium complexity agreements and change orders for strategic accounts. They will also work cross-functionally to resolve contract issues, ensure compliance, and mentor junior staff.
The Senior Clinical Data Manager provides leadership for assigned projects, ensuring global accountability and effective management of CDM deliverables. They oversee vendor performance, manage budgets, and ensure data quality compliance across complex clinical trial programs.
The CRA 2 is responsible for all aspects of study site monitoring, including routine visits, site management, and maintenance of study files. They ensure protocol adherence, data integrity, and the protection of study participants while managing serious adverse event reporting.
The Hosting Architect will lead the enterprise transition from on-premises datacenters to a modern, automated Azure-based cloud platform. This role is responsible for designing hybrid architectures, governing cloud migrations, and implementing AI-driven operations to improve scalability and reduce costs.
Perform clinical site monitoring activities including initiation, routine visits, and close-outs to ensure data quality and patient safety. Manage clinical sites in accordance with project plans, SOPs, and regulatory requirements while collaborating with sponsors and investigators.
Develop and validate SAS programs for complex oncology clinical trials to support data analysis, reporting, and regulatory submissions. Collaborate on the creation of SDTM and ADaM datasets while ensuring compliance with industry standards and study timelines.
The role involves leading and managing clinical trial sites across varied and complex indications while building trusted relationships with investigators and study teams. Key duties include ensuring paramount patient safety and data integrity, and actively contributing to innovative and first-in-class studies.
This role is responsible for the comprehensive coordination of site-level activities during the start-up phase of clinical studies, acting as the single point of contact for investigative sites to ensure smooth progression and regulatory compliance. Key duties include site activation, support, training, and collaboration between sponsors, CROs, and site staff, while protecting patient rights and safety.
This role coordinates comprehensive site-level activities from study start-up through maintenance, serving as the primary contact for investigative sites to ensure smooth progression and regulatory compliance. Responsibilities include overseeing site activation tasks, identifying and assessing research sites, managing essential document collection, and supporting ongoing site compliance and study team milestones.
The role involves planning, executing, and overseeing all programming activities for complex studies, including resource estimation, budget adherence, and timeline management. Responsibilities also include overseeing SDTM, ADaM, and TLF development, performing senior reviews, and supporting submission activities.
The Senior Clinical Data Manager will lead studies and manage all data management deliverables from study start-up to database lock. This role includes client-facing activities, project documentation development, and mentoring junior staff.
