TMF Coordinator
About this role
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.
\nTMF 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
- 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
- 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
- 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
- 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
- Manage multiple studies and priorities simultaneously
- Deliver against timelines and project milestones
- Handle high document volumes efficiently and accurately
- Demonstrate proficiency in eTMF and document management systems
- Utilize Microsoft Office tools (Excel, Word, SharePoint) for reporting and coordination
- Identify opportunities to optimize TMF processes and workflows
- Drive best practices and standardization
- Stay informed on regulatory and industry developments
- 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
Company at a glance
Industry-leading specialty GI contract research organization (CRO) transforming clinical trial outcomes and accelerating the development of life-changing therapies. We bring together deep GI expertise, advanced medical imaging solutions, clinical operation excellence and cutting-edge precision medicine/laboratory services.
With a global network of 5,000+ sites in >60 countries and growing, we expedite study activation and maximize patient enrollment, ensuring efficient and impactful clinical trials. Trusted by pharmaceutical and biotech partners, we support over 70% of all IBD compounds in development today – delivering customized end-to-end solutions to bring novel therapies to market.
As a full-service CRO, our offering is tailored to meet your specific clinical research needs:
- Clinical Trial Services
- Medical Monitoring
- Medical Imaging Solutions
- Medical Research & Development
- Medical Writing
- Precision Medicine/Biomarkers
- Clinical Pharmacology
- Histopathology via Specialty Lab, AcelaBio
- Spatial Biology
- Statistics
- Real-World Evidence
Headquartered in London, Ontario, Alimentiv operates with globally across Canada, the US, Europe, Asia-Pacific, and Latin America.
Top Benefits
- Bonus
Tired of cold applications?
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Know someone who'd be great for this?