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.

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