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: 2; 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
Apply ALCOA+ data integrity principles
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 clear guidance on TMF requirements and processes
Support audit and inspection readiness activities
Required Qualifications & Experience
- Bachelor’s degree in Life Sciences or a related field (preferred)
- 1-3 years experience in clinical trials TMF management
- Working knowledge of eTMF platforms and regulatory requirements
- Strong understanding of clinical trial record management and quality standards
- Working remotely
Core 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
