The role is responsible for managing budgets, timelines, and quality guidelines for regulatory projects to ensure deliverables are met. Key duties include managing high-quality submissions to regulatory authorities and mitigating project risks.
Fortrea
144 Remote Job Openings at Fortrea
Oversee the financial and operational delivery of a clinical study portfolio to ensure quality, budget adherence, and timely execution. Drive business growth by contributing to new opportunities and maintaining senior-level client relationships.
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.
Assist with clinical safety operations by processing adverse event reports and managing expeditable safety data. Responsible for data entry, writing patient narratives, and submitting reports to regulatory agencies within required timelines.
The CTA is responsible for executing clinical research projects by maintaining documentation, tracking study activities, and providing administrative support to the project team. Key duties include managing the Trial Master File (TMF), coordinating study supplies, and liaising with vendors to ensure regulatory compliance.
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.
Drug Safety Associate - AE Intake & Follow Up - Client Dedicated - Toronto, Canada
Fortrea
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Full Time
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a day ago
Fortrea
Manage end-to-end pharmacovigilance activities, including processing adverse event reports from clinical and post-marketing sources. Ensure timely regulatory reporting, maintain safety databases, and coordinate follow-up for missing information.
Oversee and optimize end-to-end safety case processing workflows to ensure timely regulatory reporting and compliance. Monitor workload distribution, track performance metrics, and lead initiatives to improve data quality and efficiency.
Coordinate and support the delivery of Phase I clinical trials, including managing study documents and tracking milestones. Act as a primary point of contact for internal teams and external sites while managing CTMS and eTMF systems.
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.
Sr. Clinical Project Manager or Clinical Project Manager II - Ophthalmology
Fortrea
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Full Time
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2 days ago
Fortrea
Lead the operational strategy and end-to-end lifecycle of ophthalmology clinical trials, ensuring projects are completed on time and within budget. Manage client relationships and lead high-performing matrixed teams to deliver contracted deliverables while maintaining quality and regulatory compliance.
Sr. Clinical Project Manager or Clinical Project Manager II - General Medicine
Fortrea
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Full Time
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2 days ago
Fortrea
The Project Manager is responsible for the operational strategy, budget, and timeline of clinical trials within General Medicine. They lead cross-functional teams and manage the end-to-end project lifecycle to ensure quality and customer satisfaction.
Sr. Clinical Project Manager or Clinical Project Manager II - Oncology
Fortrea
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Full Time
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2 days ago
Fortrea
Lead the operational strategy and end-to-end lifecycle of oncology clinical trials, ensuring projects are completed on time and within budget. Manage client relationships and lead cross-functional teams to drive project performance and operational excellence.
Support the Lead Data Manager in reviewing and maintaining external vendor data to ensure data integrity and consistency. Manage data discrepancies, resolve query issues, and coordinate local laboratory normal ranges with clinical staff.
The Project Manager is responsible for the operational strategy, budget, and timeline of Cell & Gene Therapy clinical trials. They lead high-performing matrix teams to ensure project delivery meets customer needs and regulatory standards.
The role involves managing quality reviews, compiling metrics, and drafting corrective and preventive actions (CAPAs) for global regulatory submissions. It also requires reviewing adverse event reports and coordinating with project teams to support client audits and regulatory inspections.
Provide enterprise oversight of quality and compliance systems to ensure adherence to laws, regulations, and sponsor requirements across global operations. Lead the portfolio quality strategy, governance forums, and the design of a scalable Quality Operating System to drive systemic prevention and risk mitigation.
Execute risk management processes and documentation for surgical procedures and new combination product development. Provide quality oversight throughout the product lifecycle and collaborate with stakeholders to implement risk mitigation and CAPA plans.
Responsible for site management and monitoring of clinical trials to ensure compliance with SOPs, ICH GCP guidelines, and sponsor requirements. Key tasks include conducting site visits, verifying data integrity, and ensuring the protection of study subjects.
Assist with Clinical Safety and PSS operations, including the processing and submission of adverse event reports to regulatory agencies. Perform case intake, triage, and data entry while ensuring compliance with quality management systems and timelines.
Sr. Clinical Project Manager or Clinical Project Manager II - Ophthamology or Cell & Gene Therpy
Fortrea
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Full Time
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6 days ago
Fortrea
The Project Manager is responsible for the operational strategy, budget, and timeline of clinical trials while maintaining quality and customer satisfaction. They lead high-performing matrixed teams and manage the end-to-end lifecycle of projects with a focus on risk mitigation and patient centricity.
The role involves collecting and analyzing primary and secondary data to support client engagements and deliverables. Responsibilities include preparing reports, presentations, and recommendations aligned with client needs in the HEOR space.
Oversee domestic and global clinical projects focusing on cell and gene therapy, managing scope, cost, quality, and risk. Act as the primary client contact and lead cross-functional teams to ensure operational excellence and regulatory compliance.
Responsible for generating business leads and managing inbound client interactions to achieve quarterly and annual goals. Supports business development by qualifying leads and collaborating with internal teams to ensure high customer satisfaction.
Develop and maintain programs for dataset creation, data import, and transformation using SAS and other tools. Support clinical databases and create CRF annotations and mapping specifications according to CDISC standards.
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.
Coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Ensures regulatory compliance, manages essential documents, and facilitates site activation through collaboration with sponsors and CROs.
Manage and grow assigned accounts to achieve annual sales targets and revenue goals. Lead client engagement, develop strategic account plans, and utilize SFDC for pipeline forecasting and opportunity management.
Lead the end-to-end development cycle of high-complexity Phase II-IV clinical regulatory documents for a leading pharma partner. Coordinate cross-functional teams to author protocols, IBs, and briefing packages while ensuring alignment with project strategy.
The role involves managing local laboratory data for clinical trials to ensure accuracy, compliance, and high-quality deliverables. Responsibilities include configuring analyte parameters in Veeva Vault and collaborating with cross-functional teams from study start-up to database lock.
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.
Coordinate the delivery and logistics of clinical and ancillary supplies for international studies across Europe. Manage importation processes, label reviews, and vendor relationships to ensure compliant supply distribution.
Assist with Clinical Safety and PSS operations, focusing on processing adverse events and submitting them to clients and regulatory agencies. Support the Global Safety lead in preparing safety management plans, reports, and documentation for audits.
Manage complex clinical projects and ensure site monitoring adheres to SOPs, ICH Guidelines, and GCP. Lead process improvement initiatives and mentor new team members on trip report review and quality checks.
Lead clinical data management activities from study start-up to database lock, ensuring compliance with protocols and GCP standards. Manage client relationships, oversee project documentation, and provide leadership and mentorship to the internal study team.
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.
Senior Regulatory Medical Writer - Client Dedicated - Canada
Fortrea
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Full Time
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9 days ago
Fortrea
Lead the full development lifecycle of Phase II–IV clinical regulatory documents, including protocols and investigator's brochures. Coordinate cross-functional teams and translate clinical data into compliant regulatory submissions for a global pharmaceutical sponsor.
Centralized Clinical Team Lead I / Centralized Clinical Team Lead II - Ukraine
Fortrea
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Full Time
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9 days ago
Fortrea
Lead and mentor a team of Central Monitors to ensure high-quality data review and efficient study oversight. Collaborate cross-functionally to drive risk-based monitoring strategies and ensure regulatory compliance.
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 architecture, audit compliance, and integration security.
Lead the design, development, and governance of Workday integrations and reporting solutions across HCM and Financials. Supervise a team of specialists to ensure scalable architecture and high-quality data insights for business decision-making.
Contribute to the architectural vision for data integration and master data management strategies. Design and implement scalable ETL workflows and data repositories to improve drug development speed and quality.
Support the end-to-end acquisition and quality of third-party clinical trial data while ensuring audit readiness and compliance. Collaborate with external vendors and cross-functional teams to resolve data inconsistencies and optimize integration processes.
Lead and oversee local laboratory data activities for clinical studies, ensuring accurate and compliant data delivery from startup to database lock. Collaborate with CROs, vendors, and internal cross-functional teams to maintain data standards and improve processes.
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 discrepancies and meet study deliverables.
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 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 role focuses on managing site start-up activities for early-phase clinical trials, ensuring timely regulatory submissions and approvals. It involves coordinating essential documentation and serving as the primary contact for investigative sites to enable efficient study activation.
The Costing Manager supports Costing Directors in delivering clinical study costings and managing the full RFP process. This includes reviewing scopes, adjusting budgets, and coordinating with various functional roles to ensure alignment with delivery strategies.
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.
Drive revenue growth by leading pre-sales motions and accelerating the adoption of Fortrea Intelligent Technology (FIT) solutions. This role involves shaping deals, creating value-based business cases, and managing executive-level relationships with pharmaceutical and biotech sponsors.
Drive revenue growth by accelerating the market adoption of Fortrea Intelligent Technology (FIT) solutions through strategic pre-sales and deal-shaping. Lead executive-level discovery, value storytelling, and bid strategies to improve win rates across various clinical trial delivery models.
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 role involves managing all aspects of clinical site monitoring, including initiation, routine visits, and close-out for oncology trials. Key duties include ensuring patient safety, verifying informed consent, and maintaining data integrity through CRF review and SAE reporting.
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 all aspects of clinical site monitoring, management, and closeout in accordance with SOPs and regulatory guidelines. Acts as a lead monitor or local project coordinator, ensuring data integrity and patient protection across cardiac and medical device studies.
Provide HR administrative support for the DACH region, primarily handling written queries via ServiceNow and email. Manage employee documentation, payroll paperwork, and onboarding/offboarding processes for German-speaking stakeholders.
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.
The Senior Site Navigator coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Responsibilities include managing regulatory submissions, negotiating contracts and budgets, and ensuring compliance with ICH/GCP guidelines.
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 via Case Report Forms.
Perform unblinded monitoring activities and oversee Investigational Products in accordance with ICH-GCP guidelines. Ensure protocol compliance, data integrity, and patient safety while managing relationships with site pharmacies.
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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16 days 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.
Responsible for technical oversight of dictionary coding activities and thesaurus management for global medical projects. Collaborates with cross-functional teams to ensure the delivery of high-quality coded clinical data according to project timelines and budgets.
Responsible for all aspects of study site monitoring, including initiation, routine monitoring, and close-out of clinical sites. Ensures the protection of study patients and the integrity of data submitted via Case Report Forms.
Senior CRA II Sponsor Dedicated based in Munich, Düsseldorf or Berlin regions
Fortrea
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Full Time
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19 days 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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19 days 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.
The role involves executing global revenue recognition and forecasting for assigned studies and projects according to month-end and mid-month calendars. It also requires providing historical financial analysis and recommendations to drive business performance and maintaining system ledgers in Workday.
The Senior CRA I is responsible for clinical site monitoring, management, and ensuring adherence to regulatory guidelines and project plans. This includes conducting site visits, managing study files, and acting as a lead monitor or local project coordinator.
Lead complex statistical studies and NDA submissions, providing oversight for statistical analysis plans and TFL reviews. Manage project timelines, resource planning, and provide mentoring to junior staff while serving as a subject matter expert during audits.
Responsible for all aspects of clinical study site monitoring, including routine visits, closeouts, and ensuring data integrity. The role involves managing site resources, verifying protocol adherence, and liaising with vendors and internal work groups.
Support site activation activities and facilitate collaboration between study teams and clinical sites. Responsibilities include managing regulatory submissions, tracking site readiness, and coordinating administrative tasks for contracts and budgets.
Senior Cybersecurity Analyst (SOC Lead) - Poland and Bulgaria
Fortrea
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Full Time
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22 days ago
Fortrea
Lead sophisticated cyber forensic investigations and spearhead the SOC's threat detection and incident response efforts. Collaborate with architecture teams to refine security incident management and integrate advanced forensics into daily operations.
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 essential document collection and quality review.
Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)
Fortrea
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Full Time
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22 days 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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23 days 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.
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 tasks, and handles contract and budget negotiations.
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.
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.
Responsible for reviewing investigator packages, informed consent forms, and patient recruiting materials to ensure compliance with regulatory and GCP guidelines. The role also involves filing documentation in TMF/eTMF and providing input for Corrective and Preventative Actions (CAPAs).
The lead is responsible for developing and analyzing feasibility and site selection strategies for global clinical trials using primary and secondary data. They manage global feasibility projects, contribute to bid defenses, and transition site selection strategies to operational teams.
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.
Lead the strategic direction and operational excellence of the Workday platform across Finance and enterprise functions. Manage a team of specialists and partner with executive leadership to ensure system scalability, compliance, and optimization.
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.
Lead the management, optimization, and configuration of Workday PSA solutions to support finance and operational needs. Collaborate with cross-functional teams to align the PSA roadmap with enterprise leadership and ensure seamless data integration.
The Senior CRA is responsible for site monitoring and management of clinical studies, ensuring adherence to SOPs and regulatory guidelines. Key duties include conducting site visits, verifying patient safety and data integrity, and managing project timelines and budgets.
Sponsor dedicated Senior Clinical Research Associate (w/m/d) - home based
Fortrea
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Full Time
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a month 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.
Coordinate clinical data review, query resolution, and reconciliation activities to ensure data integrity and quality. Assist in developing Data Management Plans and serve as a backup to the Clinical Data Manager.
Lead data management activities from study start-up to database lock, ensuring deliverables meet quality expectations, timelines, and budgets. Act as a subject matter expert for sponsors and provide guidance, mentoring, and training to junior data management staff.
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.
Manage the end-to-end proposal process, including the development of budgets, timelines, and written responses for client requests. Coordinate with internal experts and external vendors to deliver competitive proposals for low to medium complexity opportunities.
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 across global cross-functional teams in a matrix environment.
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.
Lead complex clinical trials and New Drug Applications by developing Statistical Analysis Plans and providing statistical oversight. Manage project timelines, resource planning, and provide mentoring to junior staff while serving as a Subject Matter Expert.
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.
Clinical Research Associate (CRA I/II) – Phase I Trials – Portugal
Fortrea
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Full Time
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a month ago
Fortrea
The role involves conducting routine and close-out monitoring visits to ensure clinical site compliance and patient protection. It also requires managing data quality through source document verification and tracking safety reports for Phase I trials.
CRA 1 / CRA 2 - Full Service Operation Model - Porto, Portugal
Fortrea
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Full Time
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a month ago
Fortrea
The role involves managing clinical studies in Oncology, Hematology, and Immunology through site monitoring, data quality oversight, and patient protection. Responsibilities include conducting site visits, managing safety reporting for SAEs, and coordinating with internal teams and vendors.
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.
Manage clinical trial sites by performing monitoring visits and ensuring patient safety and protocol adherence. Maintain data integrity through source data verification and oversee regulatory documentation and investigational product accountability.
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.
Director Strategic Delivery & Growth (United States or Asia)
Fortrea
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Full Time
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a month ago
Fortrea
Lead the design and execution of innovative operational delivery strategies to grow and maintain a profitable portfolio of clinical business. Manage senior client relationships and oversee post-award strategy implementation to ensure project deliverables meet regulatory and company 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.
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 facilitates collaboration between sponsors, CROs, and clinical staff.
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.
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.
Sr. CRA 2, FSP - Oncology - Montreal, Canada - French Speaking
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 visits, close-outs, and site management. Ensures the protection of study patients and the integrity of data submitted on Case Report Forms.
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 strategy, development, and lifecycle of data management products for the life sciences sector. Bridge the gap between technology and business to ensure products meet industry standards and strategic business goals.
Medical Device & Diagnostics - CRA 2 - US Remote - French Speaking
Fortrea
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Full Time
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2 months ago
Fortrea
The CRA will lead and support the Medical Device & Diagnostics team by managing all aspects of study site monitoring, including routine visits and close-outs. They are responsible for ensuring protocol adherence, data integrity, and the protection of study participants through rigorous clinical research standards.
IT Internal Communications & Marketing – Facilities Administrator Intern
Fortrea
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Full Time
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2 months ago
Fortrea
The intern will support clinical platforms and infrastructure teams by contributing to cloud initiatives, technical debt remediation, and application modernization. They will also engage in agile project management and assist with front-end development tasks.
The Senior Technical Designer leads eCRF design and database programming within the Medidata Rave EDC system for clinical trials. They are responsible for preparing specifications, performing quality control, and providing guidance to team members to ensure project consistency and compliance.
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.
Sr. CRA 2, FSP - Invitro Diagnostics - East Coast, Midwest & West Coast
Fortrea
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Full Time
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2 months ago
Fortrea
The Senior Clinical Research Associate is responsible for all aspects of study site monitoring, including initiation, routine monitoring, and close-out visits. They ensure protocol adherence, data integrity, and the protection of study participants while managing site and registry activities.
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 CRA I is responsible for all aspects of clinical site monitoring, including routine monitoring, closeout visits, and ensuring data integrity through source document review. They also manage site activities, maintain study files, and act as a liaison between vendors and internal project teams.
The Therapeutic Strategy Leader contributes to therapeutic area strategy and provides medical and scientific leadership to support business development and growth. They ensure the delivery of MedSci activities in compliance with regulatory standards while building strong relationships with clients and key opinion leaders.
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.
The Site Navigator oversees site-level activities throughout the clinical study lifecycle, ensuring regulatory compliance and effective site activation. They serve as the primary point of contact for investigative sites, managing contracts, budgets, and essential documentation to ensure study milestones are met.
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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2 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 CRA 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 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 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 guidance on clinical development, market access, and value demonstration across product lifecycles.
The CRA II/Senior CRA is responsible for performing site monitoring activities, including qualification, initiation, and close-out visits to ensure protocol compliance. They also manage site relationships, ensure data integrity, and track serious adverse events while supporting cross-functional project execution.
Responsibilities include leading and supporting the Full Service Outsourcing team by overseeing all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. The role also involves ensuring patient safety, adherence to protocol, data integrity verification via source document review, and managing Serious Adverse Event reporting.
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.
Responsibilities include leading and supporting site monitoring activities such as routine monitoring, initiation, and close-out visits, ensuring adherence to protocol and regulatory requirements for participant safety and data integrity. This involves managing study files, liaising with vendors, handling Serious Adverse Event reporting, and performing CRF review and query resolution.
This specialist supports clinical development strategy and external site partnerships by analyzing site capabilities, feasibility data, and performance metrics, collaborating with commercial and operational teams to provide strategic insights. Key duties include maintaining study resourcing databases, conducting Fair Market Value reviews, generating baseline budgets, and developing evidence-based clinical trial strategies.
The role involves leading and supporting clinical trial monitoring activities, ensuring high standards of care for participants, and responding to emergencies based on clinical research standards. Responsibilities cover all aspects of study site monitoring, including routine monitoring, close-out visits, vendor liaison, and comprehensive site management as per project plans.
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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3 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 role involves conducting all aspects of study site monitoring, including routine visits, initiation, and close-out activities, while ensuring patient safety and data integrity according to project plans and SOPs. Responsibilities also include managing monitoring tasks efficiently, preparing timely reports, and collaborating with internal teams on project needs and resources.
The Medical Contact Center Associate I is responsible for responding to medical information queries and reporting adverse drug reactions. They will execute drug safety data management processes and support various activities as assigned.
Plan, execute, and oversee all programming activities on a study, ensuring quality and adherence to timelines. Mentor less-experienced team members and liaise with other departments for programming needs.
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.
