Maintain inspection-ready Trial Master File documentation by filing, indexing, and quality-checking records in eTMF systems. Ensure compliance with ICH-GCP, FDA, EMA, and ALCOA+ requirements; investigate discrepancies, resolve documentation gaps, support audits and inspections, report TMF metrics, and collaborate with study teams on outstanding documentation and process improvements.
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
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