Senior Clinical Trial Manager
climbbio · Wellesley Hills
Job description
About the role
Climb Bio is seeking an experienced, self‑motivated Senior Clinical Trial Manager to lead end‑to‑end delivery of Phase 1‑3 studies, with immediate focus on Phase 1/2 execution and development of scalable clinical operations processes.
Key responsibilities
- Serve as the Clinical Operations representative on project teams, driving study‑level operational execution and issue resolution across Clinical Development, Regulatory, Data Management, Safety, Statistics and CMC.
- Own end‑to‑end trial delivery, including conduct, inspection readiness, TMF health, investigational product supply and regulatory submissions support, with proactive risk assessment and escalation.
- Lead CRO and vendor performance, ensuring quality, timeline and budget adherence while resolving issues and recommending trade‑offs.
- Support study startup, audits and inspections, and prepare accurate trial status reports for leadership.
Required profile
- Bachelor’s degree with at least 6 years of independent clinical trial management experience across Phases 1‑3.
- Minimum 2 years in a small biotech, successfully managing multiple trials and scaling processes.
- In‑depth knowledge of GCP, clinical research processes and regulatory requirements.
- Excellent communication and interpersonal skills for managing external relationships.
- Ability to travel occasionally (≈20%).
Required skills
- Proficiency in Microsoft Office Suite.
What we offer
- Base salary commensurate with experience, discretionary annual bonus.
- Comprehensive benefits: medical, dental, vision, disability, life insurance, 401k match.
- Generous paid time off, holidays and stock options.
- Remote or hybrid work option based out of Wellesley, MA.
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Published 7 hours ago
Expires 1 month from now
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climbbio
Wellesley Hills
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