Job Overview
Location
2 Locations
Job Type
Full-time
Category
Other Engineering
Date Posted
April 22, 2026
Full Job Description
📋 Description
- • Lead process development, evaluation, and implementation activities or projects in conjunction with CDSO Process Excellence and Global Development Compliance for functions including Clinical Data Operations & Standards, Medical Writing, Testing, Innovation & Data Enablement, and Development Systems & Digital Strategy.
- • Drive process activities by developing comprehensive project plans, timelines, and communication strategies, ensuring alignment across diverse stakeholders and subject matter experts.
- • Lead and support new process and technology implementation across studies, collaborating with study team members.
- • Identify potential process documentation gaps and collaborate with the CDSO Process Excellence and Delivery team and other functions to propose and implement mitigations.
- • Lead or support CDSO Process Excellence and Delivery team’s participation in inspection and audit readiness activities.
- • Lead or support process activities associated with transfer of clinical trial execution activities due to acquisitions and mergers, working with various stakeholders to ensure compliance to processes.
- • Provide project management support within the CDSO Process Excellence and Delivery team to assist in managing work allocation, project status reporting, team communications, and meeting management.
- • Foster strong working relationships with cross-functional SMEs and stakeholders to align on strategic objectives, gather expert input, and drive decision-making in a matrix environment.
- • Support CDSO Business Process Owners (BPOs) by coordinating initiatives, tracking deliverables, and facilitating stakeholder engagement across functional teams.
🎯 Requirements
- • Bachelor’s Degree or international equivalent required; Life Sciences preferred.
- • 8 or more years’ experience in the pharmaceutical industry or clinical research organization, including clinical data management/clinical trial data delivery & study reporting.
- • 8 or more years of operational experience in project management, process improvement, clinical data management/EDC build and programming, IRT/eCOA implementation and management, data transfers/ingestion, centralized monitoring, and/or regulatory submission experience.
- • Experience in audit and inspection preparation and conduct for clinical data management activities.
- • Experience in managing transfer of clinical data management activities from acquisitions and mergers, including effective collaboration with internal teams and external partners.
- • SME of clinical trial documents (protocols, statistical analysis plans, CRFs, data management plans, clinical study reports) and processes.
🏖️ Benefits
- • Comprehensive benefits including Medical, Dental, Vision, Life, STD/LTD, 401(K), and Flexible time off (FTO) for regular, full-time or part-time employees working 20 or more hours per week.
- • Pay range: USD $160,000-170,000.
- • Fully remote, home-based position in the USA with flexibility to work flexible hours as needed to meet business needs.
- • Opportunity to work with global teams and gain international experience in clinical data strategy and delivery.
- • Exposure to cutting-edge clinical trial technologies including EDC, IRT, eCOA, digital wearable tools, CTMS, TMF systems, centralized monitoring systems, and clinical study report generation tools.
Skills & Technologies
About Fortrea Holdings Inc.
Fortrea is a global contract research organization spun out from LabCorp in 2023 to provide drug development services across Phases I-IV. It offers clinical trial management, patient access solutions, regulatory consulting, and commercialization support to biopharmaceutical, medical device, and diagnostic clients. The company operates in more than 90 countries with 19,000 employees, leveraging therapeutic expertise in oncology, rare diseases, neuroscience, and other complex areas to accelerate therapies from lab to market while prioritizing patient experience and data-driven insights.
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