Clinical Trial Manager

NSF
Any Location, MD
Category Research
Job Description
The Clinical Trial Manager leads all aspects of clinical study execution, ensuring seamless project delivery, driving timelines, managing resources and budgets, and maintaining compliance.

Requirements

  • Lead end-to-end project management across all study phases
  • Oversee study conduct in alignment with FDA regulations, ICH-GCP guidelines, and company SOPs
  • Serve as a strategic communicator with clients, senior leadership, cross-functional teams, investigators, and site staff
  • Develop and manage project plans, budgets, resources, and risk-mitigation strategies
  • Evaluate and manage CROs/vendors to ensure quality, timeline, and budget expectations
  • Contribute to protocol development, CRFs, ICFs, operational manuals, CSRs, and regulatory submission components
  • Support IND/NDA activities and participate in regulatory interactions, bid defenses, and proposal development
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