Are you a detail-oriented and organised individual with a passion for clinical research? We’re looking for a TMF Coordinator to join our team in Bangalore. As a TMF Coordinator, you’ll play a critical role in ensuring the accuracy and completeness of clinical documentation, contributing to inspection-readiness and compliance with global regulatory requirements.
✅About the Role
In this role, you’ll provide day-to-day support for the preparation and management of TMF documents before uploading and indexing them in the eTMF system. You’ll work closely with clinical project teams and support smooth TMF operations, ensuring study-specific TMF index management and inspection readiness.
✅Key Responsibilities:
Provide Pre-QC of documents before upload and indexing in the eTMF system
Support maintenance and management of TMF records for assigned clinical trials
Ensure timely and accurate uploading, naming, and indexing of clinical documentation
Collaborate with study teams to resolve document queries and discrepancies
Maintain compliance with the DIA Reference Model for TMFs and ICH GCP guidelines
Uphold established standards for documentation accuracy, completeness, and traceability
Assist with TMF filing and document retrieval as required
Support TMF readiness for regulatory audits and inspections
✅Requirements:
1-4 years of experience in clinical operations and/or clinical document management (eTMF preferred)
Bachelor’s degree in life sciences, healthcare, pharmacy, or related field
Working knowledge of clinical research documents and regulatory guidance
Excellent communication and organisational skills
Proficiency in Microsoft Office suite (Word, Excel, etc.)
✅Desirable Skills:
Experience with Veeva Vault or similar eTMF platforms
Knowledge of the DIA Reference Model for TMFs
Experience in a fast-paced, cross-functional environment
Familiarity with eCTD binders, CSR appendices
✅What We Offer:
Opportunity to work with a leading company in the clinical research industry
Collaborative and dynamic work environment
Professional development and growth opportunities
Competitive salary and benefits package
✅Why Choose This Role?
As a TMF Coordinator, you’ll have the opportunity to develop your skills in clinical document management, regulatory compliance, and team collaboration. You’ll work closely with cross-functional teams to ensure consistent documentation processes and support TMF readiness for audits and inspections.
✅Tips for TMF Coordinators:
Stay up-to-date with industry trends and regulatory requirements
Develop strong organisational and communication skills
Build relationships with cross-functional teams and stakeholders
Consider obtaining certifications, such as the Certified Clinical Research Professional (CCRP) certification
✅TMF Career Development
A career in TMF coordination offers a wide range of opportunities for growth and development. As a TMF Coordinator, you’ll have the chance to develop your skills in clinical document management, regulatory compliance, and team leadership.
✅Benefits of Working in TMF:
Opportunity to contribute to the success of clinical trials and ensure compliance with regulatory requirements
Collaborative and dynamic work environment
Professional development and growth opportunities
Competitive salary and benefits package
📩 How to Apply
If you’re motivated, detail-oriented, and ready to grow your career in TMF coordination, apply now 👇🏻
👉 Apply Here on LinkedIn