Clinical Start-Up & Trial Lead

**Position Summary** The Clinical Start-Up & Trial Lead (Start-Up + CTL) is responsible for the strategic planning, coordination, and oversight of clinical trial start-up activities as well as the ongoing execution of clinical studies. This hybrid role ensures operational excellence from site initiation through to study close-out, serving as the primary operational point of contact for internal teams, vendors, and clinical sites. **Key Responsibilities** **Start-Up Responsibilities** * Lead country/site feasibility, site selection, and activation strategy in collaboration with project teams. * Oversee development and negotiation of site contracts, budgets, and regulatory/ethics submissions. * Track and report on start-up timelines, metrics, and bottlenecks; drive resolution. * Collaborate with Regulatory, Legal, and Contracts to ensure timely delivery of activation packages. * Ensure readiness for site initiation visits (SIVs) and coordinate site training. **Clinical Trial Lead Responsibilities** * Provide end-to-end operational oversight for the assigned study(ies), including CRO/vendor and site performance. * Lead cross-functional study team meetings and act as key escalation point for site-level issues. * Monitor overall study progress, timelines, and quality metrics; implement mitigation plans as needed. * Drive proactive risk identification and resolution, aligning with RBQM principles. * Ensure inspection-readiness through quality oversight of TMF, monitoring reports, and issue management. * Partner with data management, medical, and safety teams to ensure clean, timely data delivery. **Qualifications** **Education & Experience** * Bachelor’s degree in life sciences or a related field; advanced degree preferred. * 6+ years of clinical research experience, including significant site start-up and CTL/project management responsibilities. * Prior experience in a CRO, biotech, or pharma environment required. * Strong knowledge of ICH GCP, regulatory requirements, and clinical trial lifecycle. **Skills & Competencies** * Proven ability to manage multiple timelines and priorities with attention to detail. * Strong project leadership and stakeholder engagement skills. * Familiarity with EDC, CTMS, eTMF, and site start-up platforms (e.g., Veeva Vault, Medidata). * Excellent communication, negotiation, and team-building skills. * Solution-oriented mindset and comfort with ambiguity in fast-paced environments. **Travel Requirements** * Up to 20% domestic and/or international travel, as needed. **Why Join Us?** We offer a dynamic environment where innovation, accountability, and integrity are valued. In this dual-role position, you'll have an opportunity to shape trial success from the very beginning and carry that leadership throughout the study lifecycle. Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).