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.

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.

• 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

• 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

• 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

• 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

• 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

• Manage multiple studies and priorities simultaneously
• Deliver against timelines and project milestones
• Handle high document volumes efficiently and accurately

• Demonstrate proficiency in eTMF and document management systems
• Utilize Microsoft Office tools (Excel, Word, SharePoint) for reporting and coordination

• Identify opportunities to optimize TMF processes and workflows
• Drive best practices and standardization
• Stay informed on regulatory and industry developments

• 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

+ bonus