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.

Positions Available: 1; Note this position is cross-listed in multiple countries.

TMF Oversight & Compliance:
Maintain in-depth knowledge of TMF structures (paper and electronic)
Ensure compliance with ICH-GCP, FDA, and EMA regulations
Support inspection readiness and audit activities
Ensure proper management of essential clinical trial documentation

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

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 explicit guidance on TMF requiremen

📌 Tmf Coordinator Ahmedabad
🏢 Alimentiv
📍 Ahmedabad