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.

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