Clinical Data Strategy & Delivery Lead – FSP; US Remote Based

<div><div>Fortrea is currently seeking a US remote based Clinical Data Strategy & Delivery Lead <b>– FSP</b> to drive and support process development.</div></div><div><div><div><div><div><div><div><div><div><p></p><p><i><b>This is an (exempt) full-time, home-based position in the USA that will require willingness to work flexible hours as needed to meet business needs.</b></i></p><p></p><p><b>WHAT YOU WILL DO</b></p><p>In this role, you may independently lead projects or may provide support to the Process Excellence and Delivery team members as needed. As a Clinical Data Strategy & Delivery Lead you may provide project management.</p><p></p><p><b>Summary of Responsibilities:</b></p><ul><li><p>Lead process development, evaluation, and implementation activities or projects, in conjunction with CDSO Process Excellence and Global Development Compliance, for any of the following functions: Clinical Data Operations & Standards, Medical Writing, Testing, Innovation & Data Enablement, and Development Systems & Digital Strategy.</p></li><li><p>Drive process activities by developing comprehensive project plans, timelines, and communication strategies, ensuring alignment across diverse stakeholders and SMEs.</p></li><li><p>Lead and support new process and technology implementation across studies, collaborating with study team members.</p></li><li><p>Identify potential process documentation gaps and collaborate with the CDSO Process Excellence and Delivery team and other functions to propose and implement mitigations.</p></li><li><p>Lead or support CDSO Process Excellence and Delivery team’s participation in inspection and audit readiness activities.</p></li><li><p>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.</p></li><li><p>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.</p></li><li><p>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.</p></li><li><p>Support CDSO Business Process Owners (BPOs) by coordinating initiatives, tracking deliverables, and facilitating stakeholder engagement across functional teams.</p></li><li><p>And all other duties as assigned.</p></li></ul><p></p><p><b>Qualifications (Minimum Required):</b></p><ul><li><p>Bachelor's Degree or international equivalent required; Life Sciences preferred.</p></li><li><p>8 or more years’ experience in the pharmaceutical industry or clinical research organization, including clinical data management/clinical trial data delivery & study reporting. </p></li><li><p>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.  </p></li></ul><p></p><p><b>Experience (Minimum Required):</b></p><ul><li><p>Experience in audit and inspection preparation and conduct for clinical data management activities.</p></li><li><p>PMP or Lean Sigma Six certifications a HUGE PLUS</p></li><li><p>Experience in managing transfer of clinical data management activities from acquisitions and mergers, including effective collaboration with internal teams and external partners.</p></li><li><p>SME of clinical trial documents (protocols, statistical analysis plans, CRFs, data management plans, clinical study reports) and processes.</p></li><li><p>Driver of clinical trial technologies, including EDC, IRT, eCOA, digital wearable tools, CTMS, TMF systems, centralized monitoring systems, and clinical study report generation tools.</p></li><li><p>Excellent teamwork, organizational, interpersonal communication, active listening, conflict resolution and ability to influence without authority across various levels of organization.</p></li><li><p>Demonstrated matrix leadership and communication skills.</p></li><li><p>Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.</p></li><li><p>Global/international experience preferred, including the demonstrated ability to collaborate effectively with team members in other geographic locations.</p></li></ul><p></p><p>Applicants must be legally entitled to work in US without the need for employer-sponsored work permits. This position is not eligible for sponsorship.</p><p><i><b>Work Environment:</b></i></p><ul><li><p><i>Work is performed in an office environment with exposure to electrical office equipment.</i></p></li><li><p><i>Occasional drives to site locations with occasional travel both domestic and international.</i></p></li></ul><p></p><p><i><b>Physical Requirements:</b></i></p><ul><li><p>Frequently stationary for 6-8 hours per day.</p></li><li><p>Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.</p></li><li><p>Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.</p></li><li><p>Ability to access and use a variety of computer software developed both in-house and off-the-shelf.</p></li><li><p>Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.</p></li><li><p>Regular and consistent attendance.</p></li><li><p>Varied hours may be required.</p></li></ul><p></p><p><b>Pay Range: USD $160,000-170,000</b></p><p><b>Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">degrees/certifications,</span> as well as internal equity and market data. <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">Regular, full-time or</span> part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Flexible time off (FTO).</b></p><p></p><p><b>Application Deadline: 06/12/26</b></p><p></p><p><span>#LI-SE1 </span></p><p><span>#remote</span></p></div></div></div></div></div></div></div></div></div><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank" rel="noopener noreferrer">EEO & Accommodations request here</a><span>.</span></p>