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. 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 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. + bonus

Responsible for maintaining the quality, completeness, and compliance of Trial Master File documentation according to global regulatory standards. The role involves performing quality control checks, resolving documentation gaps, and ensuring inspection readiness through collaboration with cross-functional teams.

Requires a post-secondary education certificate and a minimum of 2 years of experience in TMF operations. Candidates must demonstrate proficiency in eTMF systems and have strong organizational and communication skills.

• Gestion du tempsSouhaitée
• Microsoft OfficeSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• TMF Management
• ICH-GCP Compliance
• FDA Regulations
• EMA Regulations
• ALCOA+ Principles
• eTMF Systems
• Veeva Vault
• Phlexglobal
• Trial Interactive
• Quality Control
• Document Indexing
• Stakeholder Engagement
• Audit Readiness
• Microsoft Office
• Analytical Thinking
• Time Management

• Healthcare
• Science & Research
• Manufacturing
• Administrative

Formation minimale

Diplôme professionnel

Expérience minimale

2+ ans

Postuler avant le

24 sept. 2026

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Not Applicable

Mode de candidature

La candidature directe est offerte