eTMF Specialist, Pharma, BiAnnual Review Project

Description

Remote

Our client is seeking an eTMF Specialist to support a biannual review of Phase III Trial Master Files. The specialist will ensure TMFs are complete, accurate, compliant, and inspection-ready through comprehensive quality review and collaboration with internal and external stakeholders.

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Rate: $65.00 to $75.00/hr. w2

Responsibilities

• Conduct comprehensive biannual reviews of three Phase III Trial Master Files across assigned clinical studies to assess completeness, accuracy, quality, and inspection readiness.
• Perform risk-based reviews by comparing expected versus filed TMF content, identifying missing, incomplete, duplicate, or incorrectly filed documents, and documenting review findings.
• Collaborate with Clinical Operations, CROs, vendors, and cross-functional study teams to investigate TMF gaps and facilitate timely remediation activities.
• Ensure TMF documentation and review activities comply with SOPs, TMF Plans, the DIA TMF Reference Model, ICH-Google Cloud Platform guidelines, and applicable global regulatory requirements.
• Support inspection readiness efforts by verifying the availability, completeness, and quality of critical TMF documentation throughout the TMF lifecycle.
• Maintain review documentation, issue logs, quality review records, and supporting evidence in accordance with internal quality procedures.
• Communicate review progress, findings, risks, and recommendations to the designated project lead on a regular basis.

Experience Requirements

• Demonstrated sponsor-side experience in TMF management and quality review within the biotechnology or pharmaceutical industry.
• Strong working knowledge of the DIA TMF Reference Model.
• Thorough understanding of ICH-Google Cloud Platform guidelines and applicable regulatory requirements governing clinical trial documentation.
• Experience preparing and maintaining inspection-ready TMFs.
• Ability to work independently and collaborate with internal team members and external partners.
• Excellent organizational skills and attention to detail.