Role OverviewHands-on Senior Clinical Trial Manager responsible for day-to-day execution of Phase I studies, partnering with cross-functional teams and external vendors to ensure studies are delivered on time, within budget, and with high data quality and compliance standards.
What You Will Do
Lead Phase 1 study execution from protocol development through CSR, support key milestones, lead feasibility assessments, develop enrollment forecasts, and provide day-to-day oversight of CROs, vendors, and sites.
Why It Might Be a Fit
The ideal candidate will have 5–8 years of Clinical Operations experience, including 4+ years as a CTM, and experience with clinical systems, study start-up through close-out, and CRO/vendor oversight.
Requirements
- Bachelors degree in scientific or health-related field
- 5–8 years Clinical Operations experience
- 4+ years as a CTM
- Hands-on management of Phase I–III clinical trials
- Knowledge of FDA, EMA, and ICH-GCP guidelines
- Experience with clinical systems (e.g., Medidata Rave, Veeva)
- Experience with study start-up through close-out
- CRO/vendor oversight and clinical trial budget tracking experience
- Strong execution and cross-functional coordination skills
- Comfortable in fast-paced, growth-stage environment
- Excellent communication skills
- Willingness to travel up to ~30%
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