TMF Coordinator

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