Senior Clinical Trial Manager

Job Summary

Leading the operational delivery of one or more cell therapy clinical trials, the full-time remote Senior Clinical Trial Manager will oversee study design through close-out, managing timelines, budgets, and vendor oversight while ensuring compliance with regulatory standards.

Key responsibilities

• Manage the day-to-day execution of assigned cell therapy trials, including study startup, site activation, enrollment, monitoring, and close-out
• Develop and manage study timelines, budgets, forecasts, and operational metrics while partnering with external vendors and CROs
• Ensure compliance with regulatory and quality standards, participate in protocol development, and monitor study progress to identify and mitigate risks

Required qualifications

• B.S. degree with a minimum of 5+ years of experience in clinical operations, specifically in managing clinical trials in biotech or pharmaceutical settings
• Established experience in Cell Therapy/CAR T studies and strong clinical study conduct experience from start-up through close-out
• Working knowledge of relevant GCPs and FDA/EMA regulations, along with current ICH GCP guidelines
• Ability to work effectively with minimal supervision and manage multiple deliverables across trials
• Experience in a small/mid biotechnology environment, demonstrating a startup mindset