TMF-Manager Job at GQR, Fremont, CA

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  • GQR
  • Fremont, CA

Job Description

Job Title: TMF Manager (Contractor)

Location: California (Primarily On-site)

Summary:

Our client, a leading biotech innovator, is hiring a TMF Manager (Contractor) to oversee Trial Master File (TMF) operations in a high-impact, inspection-ready environment. This role requires strong TMF expertise, vendor coordination skills, and a passion for maintaining document integrity and compliance.

Key Responsibilities:

  • Drive day-to-day TMF and eTMF operations.
  • Ensure SOP, KPI, and global regulation compliance.
  • Collaborate with cross-functional teams and vendors.
  • Lead quality reviews and TMF audits.
  • Maintain study-specific TMF indexes and placeholders.
  • Support archival, long-term storage, and document remediation efforts.

Qualifications:

  • 5+ years of clinical research experience with TMF/eTMF systems.
  • Strong document management, vendor oversight, and GCP compliance experience.
  • Excellent organizational and communication skills.
  • Prior management experience required.
  • Must be local and available to work on-site 4+ days per week.

Job Tags

For contractors, Local area,

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