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.