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. \n 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 Additional competencies * A post-secondary education certificate with minimum 2 years of TMF experience * 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 \n $42,000 - $70,000 a year + bonus \n

Responsible for maintaining inspection-ready Trial Master Files through document review, processing, and filing. Supports the secure file room and assists with audit preparations and archiving activities.

Requires a post-secondary education certificate and 1-3 years of related experience. Must possess strong computer literacy and the ability to adapt to a fast-paced environment with minimal supervision.

• Bonus

Identified from the job description. Confirm important requirements above.

• TMF Management
• Document Review
• ALCOA Principles
• Microsoft Office
• Archiving
• Audit Preparation
• Interpersonal Skills
• Time Management

• Healthcare
• Science & Research
• Administrative

Minimum education

Professional degree

Minimum experience

2+ years

Posting language

English

Working hours

40 hours per week

Office presence

2 days per week