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

• Bachelors 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 this dual-role position youll 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.