TMF Coordinator

We are seeking a detail-oriented and highly organized TMF Coordinator to join our TMF Operations team. In this role, you will be responsible for maintaining the quality, completeness, and compliance of Trial Master File (TMF) documentation in alignment with global regulatory requirements and company standards.  You will play a key role in ensuring that TMF content remains inspection-ready and supports clinical trial execution through effective document management and collaboration with cross-functional stakeholders.

TMF Oversight & Compliance Maintain in-depth knowledge of TMF structures (paper and electronic)

Ensure compliance with ICH-GCP, FDA, and EMA regulations

Apply ALCOA+ data integrity principles

Support inspection readiness and audit activities

Ensure proper management of essential clinical trial documentation

Document Management Accurately file, classify, and index documents within the TMF

Ensure adherence to version control and naming conventions

Utilize eTMF systems (e.g., Veeva Vault, Phlexglobal, Trial Interactive)

Maintain consistency and compliance of TMF structure

Quality Control Perform QC checks on TMF documents and metadata

Identify and resolve missing, incomplete, or inconsistent records

Ensure overall accuracy, completeness, and timeliness of TMF content

Support TMF health checks and reporting metrics

Issue Resolution & Continuous Improvement Investigate and resolve TMF gaps and discrepancies

Troubleshoot filing and system-related issues

Contribute to process improvements and standardization initiatives

Support root cause analysis for quality issues

Stakeholder Engagement Collaborate with study teams and Proactively follow up on outstanding documentation

Provide clear guidance on TMF requirements and processes

Support audit and inspection readiness activities

Delivery & Execution Manage multiple studies and priorities simultaneously

Deliver against timelines and project milestones

Handle high document volumes efficiently and accurately

Systems & Tools Demonstrate proficiency in eTMF and document management systems

Utilize Microsoft Office tools (Excel, Word, SharePoint) for reporting and coordination

Continuous Improvement Identify opportunities to optimize TMF processes and workflows

Drive best practices and standardization

Stay informed on regulatory and industry developments

Additional competencies Strong attention to detail and quality focus

Excellent organizational and time management skills

Effective communication and stakeholder engagement

Analytical thinking and problem-solving ability

Ability to manage multiple priorities in a fast-paced environment