Job description

rial Master File (TMF) Manager Contractor

POSITION SUMMARY
The TMF Manager Contractor will support day-to-day management of Trial Master File (TMF) operations, including TMF projects, key performance indicators (KPIs), electronic TMF (eTMF) systems, vendor TMF activities, and functional subject matter expertise. This role requires strict adherence to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Good Documentation Practices, International Council for Harmonization (ICH) E6(R2) guidelines, and ALCOA+ standards. The candidate will collaborate with both internal cross-functional teams and external vendors to ensure effective TMF management and compliance with applicable global regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Provide day-to-day support for Clinical Operations Teams and eTMF systems to ensure documentation quality and regulatory compliance
Manage TMF projects and foster collaborative relationships with internal teams and external vendors
Serve as the primary point of contact for TMF-related meetings, discussions, and requests from CROs, vendors, and internal stakeholders
Collaborate with Clinical Teams to develop and maintain TMF Plans and TMF Indexes; define expected documents for each study and ensure appropriate placeholders are maintained in the eTMF system
Perform risk-based TMF quality control and health checks as part of sponsor oversight and audit readiness
Ensure compliance with applicable TMF SOPs, KPIs, process guidance, and regulatory requirements
Conduct document-level quality reviews and coordinate resolution of quality issues with document owners
Prepare and deliver TMF metrics (Core, Country, Site level) with a focus on completeness, quality, and timeliness trends
Oversee remediation of documents failing quality checks and provide best practice recommendations as needed
Coordinate document archiving and ensure long-term storage and integrity per retention policies
Lead TMF trainings and workshops; facilitate regular meetings with CROs and vendors
Model core professional values including passion, integrity, innovation, and a patient-centered focus

REQUIREMENTS

Education:

Bachelor’s degree (BS/BA) or equivalent required

Experience:

Strong preference for local candidates due to on-site expectations (minimum four days per week)
Ability to quickly adapt to shifting priorities and business needs
Minimum of 5 years of clinical research experience, including TMF document management, vendor oversight, and quality/completeness reviews
Prior team or project management experience required
Familiarity with eTMF systems and document management platforms
Strong understanding of the drug development process, ICH GCP guidelines, clinical trial documentation, SOP application, and medical terminology
Excellent written and verbal communication skills
Strong attention to detail, organizational, and time-management abilities
Proficiency with Microsoft Office products, including Word and Excel