Senior Clinical Trial Manager

Added
11 days ago
Type
Full time
Salary
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Related skills

vendor management ema fda study startup ich-gcp

๐Ÿ“‹ Description

  • Lead day-to-day management of Phase Iโ€“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.

๐ŸŽฏ Requirements

  • Bachelor's in Life Sciences; advanced degree preferred.
  • Approximately 7+ years in clinical operations (biotech/pharma/CRO).
  • Operational lead for Phase Iโ€“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.

๐ŸŽ Benefits

  • Medical, dental, and vision coverage.
  • 401k with company matching.
  • Equity compensation.
  • Equal employment opportunity employer description included in postings.
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