Oakland, CambridgeFull TimeHealthcare
Remotely
vendor managementcro managementfdaich gcpstudy startupemaphase iphase ii
Job Description
📋 Description
- Lead day-to-day management of Phase I–II trials across portfolio companies.
- Partner with Senior Director to execute study strategy, timelines, risks.
- Develop study plans, enrollment forecasts, recruitment tools.
- Oversee study startup: site feasibility, regulatory submissions, vendors.
- Monitor study performance; identify risks and mitigation plans.
- Review monitoring reports and study metrics for quality oversight.
🎯 Requirements
- Bachelor's in Life Sciences; advanced degree preferred.
- Approximately 7+ years in clinical operations (biotech/pharma/CRO).
- Operational lead for Phase I–II studies with CRO/vendor oversight.
- Working knowledge of ICH-GCP, FDA, EMA regulations.
- Experience managing timelines, budgets, risks in lean, multi-priority settings.
- Strong organizational, project management, and communication skills.
🎁 Benefits
- Medical, dental, and vision coverage.
- 401k with company matching.
- Equity compensation.
- Equal employment opportunity employer description included in postings.