TMF Coordinator

alimentiv-2· Clinical Services - TMF Operations
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📍 Calgary, Alberta📍 Kingston, Ontario📍 Kitchener, Ontario📍 London, Ontario📍 Montreal, Quebec📍 Ottawa, Ontario📍 Toronto, Ontario📍 Vancouver, British Columbia📍 Windsor, OntarioFull time, Permanent💰 CAD 42K–70K

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.

 

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 direct full-time 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

Frequently Asked Questions

What is the salary for the TMF Coordinator role at alimentiv-2?
The listed salary for this TMF Coordinator position at alimentiv-2 is CAD 42K–70K. This is an Full time, Permanent role.
Where is the TMF Coordinator position at alimentiv-2 located?
This TMF Coordinator role at alimentiv-2 is based in Calgary, Alberta, Kingston, Ontario, Kitchener, Ontario, London, Ontario, Montreal, Quebec, Ottawa, Ontario, Toronto, Ontario, Vancouver, British Columbia, Windsor, Ontario. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the TMF Coordinator role at alimentiv-2 full-time or part-time?
This is listed as a Full time, Permanent position. It is posted as a TMF Coordinator role in the Clinical Services - TMF Operations department at alimentiv-2.
Which team or department does the TMF Coordinator at alimentiv-2 belong to?
This TMF Coordinator position is part of the Clinical Services - TMF Operations department at alimentiv-2. See the full job description for more information about the team structure and responsibilities.
How do I apply for the TMF Coordinator position at alimentiv-2?
Click the "Apply Now" button on this page. You will be redirected to alimentiv-2's official application portal hosted on lever where you can submit your application directly.
When was the TMF Coordinator job at alimentiv-2 posted?
This TMF Coordinator position at alimentiv-2 was posted on Sep 8, 2026. Apply as soon as possible — early applications are often reviewed first.
TMF Coordinator
alimentiv-2 · 💰 CAD 42K–70K
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You'll be redirected to alimentiv-2's official application page on Lever.