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.
Legal
Learn more about our EEO & Accommodations request here.