TMF Coordinator
Job Location:
Rio de Janeiro - Brazil
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
We are seeking a detail-oriented and highly organized TMF Coordinator to join our TMF Operations 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.
- 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
- Demonstrate proficiency in eTMF and document management systems
- Utilize Microsoft Office tools (Excel Word SharePoint) for reporting and coordination
- 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
- Bachelors degree in Life Sciences or a related field (preferred)
- 1-3 years 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
- 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
Required Experience:
IC
About Company
Accelerate your GI clinical trials with Alimentiv’s site network, clinical trial services, medical imaging, and biomarker discovery
