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.
Skills Required
- Bachelor's degree in life sciences or related field; advanced degree preferred
- 6+ years of clinical research experience
- Significant site start-up and CTL/project management experience
- Prior experience in a CRO, biotech, or pharma environment
- Strong knowledge of ICH GCP and regulatory requirements
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
