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.
Fortrea
154 Remote Job Openings at Fortrea
Executive Director, Clinical Platforms and Product Development
Fortrea
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Full Time
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2 days ago
Fortrea
The Executive Director defines and executes the clinical platforms product strategy while leading end-to-end product development and operational enablement. This role also serves as a key partner in commercial enablement, bid defense, and cross-functional leadership across the clinical technology portfolio.
The associate will respond to medical information queries and product quality complaints while managing adverse drug reaction reporting. They are responsible for executing drug safety data management processes, including call intake, documentation, and data reconciliation.
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 verification and CRF review.
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 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 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 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, act as a subject matter expert for sponsors, and oversee the implementation of data validation and project documentation.
The role involves managing quality reviews, identifying trends, and ensuring compliance with regulatory standards for safety reports and adverse events. You will also contribute to process improvements, training development, and support regulatory inspections and audits.
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.
Site Navigator II (Study Start-up Specialist) - Brisbane, Perth, Adelaide
Fortrea
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Full Time
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6 days ago
Fortrea
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.
FSP Sr. Clinical Research Associate II - Denver, CO - Oncology
Fortrea
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Full Time
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7 days ago
Fortrea
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.
Lead clinical data management activities from study start-up to database lock while ensuring compliance with protocols and quality standards. Manage client relationships, project timelines, and budgets while providing leadership and mentorship to the internal study team.
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 external parties to maintain accurate contract documentation and support departmental process improvements.
The Associate Clinical Data Manager will oversee the end-to-end acquisition of third-party clinical data to ensure integrity, quality, and audit readiness. They will collaborate with cross-functional teams and external vendors to resolve data inconsistencies and support study objectives.
The Project Coordinator is responsible for managing study-specific documentation, monitoring project timelines, and coordinating tasks for low to medium complexity clinical trials. They act as a primary point of contact for sites and sponsors while ensuring compliance with regulatory standards and internal quality processes.
Lead the development and implementation of clinical solutions using EDC tools and SAS programming to address global technical services issues. Oversee programming activities, manage study design quality control, and act as a subject matter expert for data management and reporting.
The Clinical Research Associate is responsible for site monitoring, site management, and ensuring adherence to study protocols and regulatory guidelines. They will also manage study files, conduct site visits, and oversee data integrity through source document review.
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 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 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 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.
Lead, coach, and develop a team of clinical research professionals while driving operational excellence and performance management. Ensure high standards of quality and regulatory compliance while managing resource allocation and supporting successful study delivery.
The Director will lead strategic delivery and growth initiatives by designing innovative trial strategies and fostering strong client relationships to drive business expansion. They are responsible for overseeing post-award strategy implementation, ensuring operational excellence, and mentoring teams to achieve project and financial goals.
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 Senior Clinical Research Associate will monitor clinical trials to ensure compliance with protocols and regulatory standards while managing site operations. They are responsible for conducting site visits, performing source document verification, and providing training to site staff.
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.
Clinical Research Associate II - Full Service Operations Model - Italy
Fortrea
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Full Time
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18 days ago
Fortrea
The Clinical Research Associate is responsible for all aspects of site monitoring and management, including routine monitoring visits, site closeouts, and ensuring protocol adherence. They also manage study documentation, vendor interactions, and data integrity while maintaining audit readiness at the site level.
You will lead and mentor site activation teams to drive the successful planning and activation of global clinical trials. This involves developing data-driven forecasting models, optimizing processes, and partnering with Clinical Operations to ensure site readiness.
Manage the development, negotiation, and execution of clinical trial agreements and site budgets to ensure timely study startup. Act as an escalation point for budget issues and leverage industry data to ensure fair market value and compliance with company parameters.
Senior Technical Designer - Medidata RAVE Certification required
Fortrea
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Full Time
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18 days ago
Fortrea
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.
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 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.
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.
Sr. Clinical Project Manager or Clinical Project Manager II - Oncology
Fortrea
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Full Time
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20 days ago
Fortrea
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.
Oversees domestic and global Phase I clinical projects, managing scope, schedule, cost, and quality to meet client expectations. Leads cross-functional teams and handles risk assurance, regulatory documentation, and potential line management duties.
Lead the end-to-end delivery of Healthy Volunteers and Patient Clinical Pharmacology projects while managing sponsor relationships and project budgets. Ensure quality, compliance, and audit readiness according to SOPs and ICH/GCP standards within a matrix environment.
Senior Clinical Project Manager or Project Manager II - Oncology
Fortrea
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Full Time
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23 days ago
Fortrea
The Senior Project Manager oversees domestic and global oncology projects, managing teams, budgets, risks, and stakeholder communications to ensure operational excellence. They are also responsible for regulatory documentation, line management of staff, and supporting business development efforts.
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 collaborating with study teams and sponsors.
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 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.
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.
Manage and negotiate site budgets and Clinical Trial Agreements to ensure timely study startup and contract execution. Act as an escalation point for global budget issues and develop processes to improve service delivery.
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.
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.
Sponsor Dedicated Site Budget & Contract Lead based in Switzerlandd
Fortrea
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Full Time
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24 days ago
Fortrea
Lead the development, negotiation, and execution of Clinical Trial Agreements and site budgets for assigned countries. Oversee budget setup and serve as an escalation point to ensure sites achieve 'Ready to Enroll' status on schedule.
Lead and empower site activation teams to drive the successful planning and activation of clinical trials across multiple countries. Manage EU-CTR submissions, oversee document collection, and optimize study start-up processes and SOPs.
The Project Manager is responsible for the operational strategy, budget, and timely delivery of clinical trials while maintaining quality and customer satisfaction. They lead high-performing teams in a matrixed environment to manage the end-to-end project lifecycle from scope to execution.
Sponsor Dedicated Site Budget & Contract Specialist based in Switzerland
Fortrea
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Full Time
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25 days ago
Fortrea
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.
Clinical Research Associate I - Full Service Operations Model - Italy
Fortrea
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Full Time
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25 days ago
Fortrea
Responsible for site monitoring and management of clinical studies, including routine monitoring, closeout visits, and ensuring data integrity. The role involves liaising with vendors, managing study files, and ensuring adherence to regulatory guidelines and project plans.
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.
Manage the development, negotiation, and execution of clinical trial agreements and site budgets to ensure timely study startup. Act as an escalation point for global budget issues and leverage industry tools to align with fair market value guidance.
Manage the development, negotiation, and execution of clinical trial agreements and site budgets to ensure timely study startup. Act as an escalation point for global budget issues and leverage industry data to align with fair market value guidance.
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.
Director/Senior Director, Participant Recruitment & Engagement
Fortrea
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Full Time
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a month ago
Fortrea
Lead the strategic development and execution of participant recruitment, engagement, and retention initiatives for clinical pharmacology services. Optimize multi-channel acquisition campaigns and leverage analytics to improve participant conversion and study completion rates.
Responsible for developing and negotiating Clinical Trial Agreements (CTAs) and site budgets to ensure timely study start-up. This includes liaising with legal departments, managing contract tracking databases, and ensuring compliance with global SOPs.
Assist with Clinical Safety and PSS operations, focusing on the processing and submission of expedited and periodic safety reports. Responsibilities include data entry, writing patient narratives, and maintaining adverse event tracking systems in compliance with regulatory requirements.
The role involves monitoring clinical trials through site visits to ensure protocol and GCP compliance. Responsibilities include managing investigational sites, verifying clinical data accuracy, and providing training to site staff.
CRAs & Sr. CRAs - Radiopharmaceutical Therapies - Remote US
Fortrea
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Full Time
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a month ago
Fortrea
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.
CRA 1/2 & Sr. CRAs - Oncology & General Medicine, French Speaking Desired- Canada
Fortrea
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Full Time
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a month ago
Fortrea
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.
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.
Investigator Grants Manager / Clinical Trial Costing Manager – Brazil (Remote)
Fortrea
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Full Time
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a month ago
Fortrea
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.
FSP Sr. Clinical Research Associate II - NYC Metro or PHL - Onc
Fortrea
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Full Time
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a month ago
Fortrea
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.
Monitoring Excellence Academy - OMEA - Oncology / CAR T & Gen Meds - CRA 1
Fortrea
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Full Time
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a month ago
Fortrea
Responsible for all aspects of clinical study site monitoring, including routine visits, close-outs, and site management. Ensures data integrity, patient protection, and adherence to protocol and regulatory requirements.
The Project Coordinator provides operational support to the Project Lead by managing project schedules, budgets, and risk identification tools. They facilitate team communication and ensure quality compliance and TMF documentation are maintained throughout the study.
Lead and execute global account strategies for high-impact pharmaceutical portfolios to drive revenue growth and market share. Act as the primary commercial negotiator and trusted interface for senior client decision-makers across multiple business units.
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.
Manager, Centralized, Risk-Based Monitoring & Risk-Based Quality Management (RBQM)
Fortrea
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Full Time
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a month ago
Fortrea
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.
Director of Product Engineering - Clinical Data Management / EDC
Fortrea
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Full Time
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a month ago
Fortrea
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 data integrity, subject protection, and adherence to SOPs and regulatory requirements.
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.
Senior Clinical Data Manager - sponsor dedicated - oncology
Fortrea
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Full Time
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2 months ago
Fortrea
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.
Oversee the financial and operational delivery of a clinical study portfolio to ensure quality, budget adherence, and timely execution. Drive business growth by developing client relationships and contributing to innovative clinical delivery strategies and proposals.
Oversee and manage Regulatory Authority, IRB/EC, and Third Body submissions to ensure timely project delivery and compliance. Provide regulatory expertise to project teams and clients while managing submission timelines and risk escalation.
Lead and develop a team of Commercial analysts to deliver high-quality reporting, dashboards, and data-driven insights. Drive process improvement, reporting standardization, and cross-functional partnerships to support business decision-making.
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.
Provide medical leadership and oversight for ophthalmology clinical programs across all development phases, including medical monitoring and safety review. Act as a primary client-facing representative to support business development and shape clinical strategies for proposals.
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.
Manage patient safety operations and the adverse events process for specific projects, ensuring compliant reporting to regulatory agencies. Provide leadership in harmonizing global processes, overseeing safety database entry, and preparing pharmacovigilance reports.
The role involves managing and specializing in external data within an FSP framework. The specialist will likely oversee data quality and integration from external sources.
The Clinical Trial Manager provides operational oversight of clinical research trials from site identification through database lock. This includes managing project scope, budgets, regulatory submissions, and ensuring compliance with professional standards and SOPs.
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.
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.
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.
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.
Conduct site monitoring visits including initiation, routine, and close-out while ensuring patient safety and protocol compliance. Manage site documentation, source data verification, and investigational product accountability to maintain high data quality.
Principal Consultant, Senior Director - RWE, Market Access, Regulatory (Europe)
Fortrea
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Full Time
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3 months ago
Fortrea
Lead business development efforts and manage key client relationships to drive financial objectives. Oversee the delivery of strategic consulting engagements across RWE, HEOR, and regulatory strategy to demonstrate product value.
Senior CRA II Sponsor Dedicated based in Munich, Düsseldorf or Berlin regions
Fortrea
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Full Time
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3 months ago
Fortrea
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.
Clinical Research Associate, sponsor-dedicated Home Office - Deutschland
Fortrea
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Full Time
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3 months ago
Fortrea
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.
The Clinical Team Lead is responsible for the clinical delivery of research trials, acting as the Clinical Project Manager to ensure trials meet contractual and budgetary requirements. They oversee site management, subject recruitment, and lead the clinical project strategy while managing risks and quality.
Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)
Fortrea
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Full Time
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3 months ago
Fortrea
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.
Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)
Fortrea
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Full Time
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3 months ago
Fortrea
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.
Manage regional pharmacovigilance operations and lead a team of direct and indirect reports to ensure high-quality safety services. Oversee regulatory compliance, project budgets, and the timely reporting of adverse events to clients and authorities.
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.
Sponsor dedicated Senior Clinical Research Associate (w/m/d) - home based
Fortrea
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Full Time
·
3 months ago
Fortrea
Manage all aspects of clinical site management from selection to close-out for Phase I-III studies. Provide mentoring and training for new employees and serve as a subject matter expert in customer-specific working groups.
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.
Manage the end-to-end processing and submission of adverse event reports and pharmacovigilance documents to regulatory agencies and clients. Provide leadership on safety projects, ensure global regulatory compliance, and support the training of junior safety staff.
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.
Responsible for the implementation, configuration, and support of safety systems to ensure high-quality service for internal and external clients. This includes conducting data extractions, managing system migrations, and collaborating with stakeholders to deliver business requirements.
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.
Senior or Principal Statistical Programmer - ONCOLOGY - Sponsor dedicated
Fortrea
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Full Time
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4 months ago
Fortrea
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 Senior Director is responsible for driving business development, managing key client relationships, and overseeing strategic consulting engagements. They lead cross-functional teams to deliver expert solutions in areas such as clinical development, market access, and health economics.
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.
Principal Statistical Programmer - Sponsor Dedicated, EMEA
Fortrea
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Full Time
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5 months ago
Fortrea
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.