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.