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Clinical Trial Manager

New

Skills

Clinical Operations CRO Management Electronic Data Capture (EDC) eTMF Excel ICH-GCP Compliance Monitoring Activities Risk Management Smartsheet Trial Master File (TMF)

The Clinical Trial Manager (CTM) plays a pivotal role in coordinating study operations across various workstreams under the guidance of the Study Lead. This position involves managing Contract Research Organizations (CROs) and vendors to ensure timely and budget-friendly delivery of clinical trials.

Key Responsibilities
  • Coordinate study operations across multiple workstreams.
  • Manage CROs and vendors to ensure on-time, within-budget delivery.
  • Oversee monitoring activities and review monitoring visit reports.
  • Maintain trackers, timelines, and deliverables; escalate risks with mitigation strategies.
  • Participate in cross-functional/vendor meetings and document decisions made.
  • Ensure Trial Master File (TMF) is current and inspection-ready.
Requirements & Qualifications
  • BA/BS in life sciences or related field (or equivalent).
  • 5+ years of experience in clinical operations or with a CRO/pharmaceutical company.
  • Direct site management, monitoring, or clinical operations experience.
  • Hands-on experience with eTMF, EDC, and tracking tools (Excel, Smartsheet).
  • Working knowledge of ICH-GCP and FDA/EMA regulations.
  • Strong organizational and cross-functional communication skills.

No forms. Your profile is generated instantly.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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