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.
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
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
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
Delivery & Execution
- Manage multiple studies and priorities simultaneously
- Deliver against timelines and project milestones
- Handle high document volumes efficiently and accurately
Systems & Tools
- Demonstrate proficiency in eTMF and document management systems
- Utilize Microsoft Office tools (Excel, Word, SharePoint) for reporting and coordination
Continuous Improvement
- Identify opportunities to optimize TMF processes and workflows
- Drive best practices and standardization
- Stay informed on regulatory and industry developments
Additional 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
Skills Required
- Post-secondary education certificate
- 1-3 years related experience in TMF or clinical trials
- Ability to be in office 1-2 times per week
- Demonstrated computer literacy and proven functional knowledge of Microsoft packages
- Ability to adapt to changes, adjust priorities with minimal supervision
- Good interpersonal skills to build and maintain relationships
What We Do
From 1986 to 2020 we operated as Robarts Clinical Trials and built a strong foundation in the medical research community. In 2020, we became Alimentiv but retained our commitment to clinical trials, medical imaging, and precision medicine for GI-related ailments.
