Sr. TMF Specialist - Contract

📋 Description

• Upload and maintain clinical trial documents within the Trial Master File system.
• Perform quality control reviews of TMF documents to ensure accuracy, completeness, and adherence to
• Grant and revoke user access in accordance with established TMF processes and requirements.
• Prepare and distribute weekly reports to support the timely resolution of outstanding quality
• Own periodic TMF Functional QC Review cycles and coordinate follow-up activities.
• Lead TMF completeness checks and ensure Expected Document Lists (EDLs) remain accurate and current.

🎯 Requirements

• Bachelor’s degree from an accredited institution or equivalent practical experience.
• 5+ years of relevant Trial Master File (TMF) experience.
• Fundamental understanding of filing systems, document management, and organizational tools.
• Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable CFR regulations.
• Familiarity with the CDISC Trial Master File Reference Model structure.
• Experience with Veeva Vault Clinical/eTMF is preferred.

🎁 Benefits

• $40–$50 per hour, depending on experience and location.
• Approximately 6-month contract opportunity.
• Fully remote position based in California.
• Senior-level ownership of operational TMF activities within Clinical Operations.
• Exposure to TMF quality control, completeness, reconciliation, transfer, and archival processes.
• Collaboration with CROs, vendors, functional teams, and clinical operations stakeholders.