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Contract TMF Manager
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GQR
South San Francisco, CA (In Person)
Full-Time
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Job Description
TMF Manager Consultant Position Summary The TMF Manager Consultant will support Trial Master File (TMF) operations through the day-to-day management of TMF activities, key performance indicators (KPIs), electronic Trial Master File (eTMF) systems, vendor oversight, and process compliance. This individual will serve as a subject matter expert (SME) for TMF operations while ensuring adherence to SOPs, Good Clinical Practice (GCP), Good Documentation Practices (GDP), ICH E6(R2), and ALCOA+ principles. The role requires collaboration with internal cross-functional teams and external service providers to ensure TMF quality, completeness, inspection readiness, and compliance with applicable global regulations. Key Responsibilities Support Clinical Operations teams and eTMF systems to maintain TMF quality, completeness, and compliance. Manage TMF-related projects and establish effective partnerships with internal stakeholders and external vendors. Serve as the primary point of contact for TMF-related discussions, meetings, questions, and requests involving CROs, vendors, and study teams. Develop and maintain study-specific TMF Plans, TMF Indexes, Expected Document Lists, and placeholders in collaboration with study teams and external partners. Perform risk-based TMF quality reviews and health checks to support sponsor oversight and ensure inspection readiness. Ensure compliance with applicable SOPs, TMF processes, KPIs, and global regulatory requirements. Conduct document-level quality reviews and partner with document owners to resolve deficiencies. Generate and analyze TMF metrics at study, country, and site levels, identifying trends related to quality, completeness, and timeliness. Drive remediation activities for documents that do not meet quality or inspection-readiness standards. Coordinate long-term document archiving and retention activities while maintaining document integrity. Deliver TMF training sessions and facilitate TMF governance meetings with vendors and CRO partners. Qualifications Education Bachelor's degree or equivalent experience required. Experience Minimum of 5 years of clinical research experience with a strong focus on TMF management, document control, vendor oversight, quality review, and inspection readiness activities. Demonstrated experience managing TMF operations within an eTMF environment. Prior experience leading projects, initiatives, or teams in a TMF or clinical operations setting. Strong understanding of the drug development process, clinical trial conduct, GCP, ICH guidelines, and regulatory requirements. Experience collaborating with CROs and external vendors. Skills & Competencies Ability to adapt quickly to changing priorities and business needs. Strong organizational, planning, and problem-solving capabilities. Excellent verbal and written communication skills. Strong attention to detail and commitment to quality. Ability to work independently while influencing cross-functional stakeholders. Proficiency with Microsoft Office applications and clinical document management systems. Effective training and stakeholder management skills. Work Environment Primarily onsite role with regular in-office collaboration expected.