Job Title:
GBS TMF-Co-Ordinator (eTMF-electronic Trial Master File --Coordinator)
Location:
Bangalore
Experience:
1 to 4 yrs exp
I. Job Summary
The TMF co-ordinator provides day-to-day support for the preparation and management of TMF documents before uploading and indexing in the eTMF system. This role ensures the accuracy and completeness of clinical documentation, contributing to inspection-readiness and compliance with global regulatory requirements. The TMF co-ordinator works collaboratively with clinical project teams and supports smooth TMF operations.In addition, the TMF co-ordinator is responsible for the management and maintenance of the AZ study-specific TMF index, including EDL updates and records management in the eTMF platform. The TMF co-ordinator provides day-to-day operational support to sponsor clinical trial teams, ensuring study-specific TMF index management and inspection readiness. The role includes performing periodic TMF checks, identifying gaps, and collaborating with the TMF Manager for oversight and resolution.
Key Responsibilities
II. Roles & Responsibilities:
- Provide Pre-QC (Quality Control) of documents prior to 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
- Manage study-specific TMF index and document records in the eTMF system (e.g., Veeva Vault)
- Maintain and update Electronic Document List (EDL) for assigned studies
- Provide operational support to clinical trial teams for TMF index management and inspection preparedness
- Conduct periodic TMF checks; share identified queries and gaps with the TMF Manager
- Ensure TMF records are compliant with DIA Reference Model, ICH GCP, and regulatory requirements
- Support timely and accurate filing of clinical research documents
- Collaborate cross-functionally to ensure consistent documentation processes
- Assist in TMF readiness for audits and inspections
III. Years Of Experience
The ideal candidate will have
2+ years of professional experience.
IV. Educational Qualification & Certifications (Optional)
Bachelor’s degree in life sciences, healthcare, pharmacy, or related field.
Essential
V. Skill Set Required:
- Bachelor’s degree in life sciences, healthcare, pharmacy, or related field
- Minimum of 1 year of relevant experience in clinical operations and/or clinical document management (eTMF preferred)
- Working knowledge of clinical research documents
- Knowledge of ICH GCP and regulatory guidance
- Skilled in verbal and written communication
- Computer literate; proficiency in Microsoft Office suite (Word, Excel etc)
Desirable
- 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
About SMC Squared
At SMC Squared, people are the foundation of our success. We help leading US and multinational companies accelerate digital transformation by building and managing Global Capability Centres with fully integrated, strategically aligned, and valued teams. Our people-first approach creates opportunities for talented professionals to grow, contribute, and thrive, while enabling organizations to scale intelligently.As part of Hexaware Technologies—a global leader in IT, BPO, and consulting—we deliver greater value through enhanced digital capabilities, automation platforms, and a shared commitment to people-centric transformation. Join us and be part of a purpose-driven company where your ideas matter, your work makes a global impact, and your career can reach new heights.Join us and be part of a purpose-driven company where your ideas matter, your work has a global impact, and your career can reach new heights.
EEO Statement
SMC Squared is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.If you are a creative individual with a passion for design and a drive to contribute to impactful projects, we invite you to apply for this exciting opportunity.
