SMC Squared India is hiring a GBS TMF-Coordinator to support clinical document management (eTMF) operations. This role is perfect for life science graduates with 1–4 years of experience in clinical research, TMF operations, and ICH GCP documentation. The position is based in Bengaluru North, Karnataka, offering a hybrid work setup and an opportunity to collaborate with global teams in a dynamic environment.
Job Overview
As a GBS TMF-Coordinator, you’ll ensure the accuracy, completeness, and regulatory compliance of trial master files (TMF) within clinical studies. You will work closely with global project teams, maintain study-specific TMF indexes, and support audit and inspection readiness.
Key Responsibilities
- Conduct pre-QC checks before document upload and indexing in the eTMF system
- Manage and maintain TMF records for assigned clinical trials
- Ensure timely, accurate uploading and indexing of clinical trial documents
- Resolve document discrepancies with study teams
- Maintain compliance with ICH GCP and DIA TMF Reference Model
- Perform periodic TMF checks and collaborate on gap resolution
- Support audit and inspection preparedness
- Assist with electronic document list (EDL) updates and TMF index management
- Use tools like Veeva Vault for TMF document operations
Required Qualifications
- Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, or related field
- 1–4 years of experience in clinical operations or document management
- Strong knowledge of ICH GCP and regulatory documentation processes
- Excellent communication and MS Office skills
Preferred Skills:
- Experience with Veeva Vault or other eTMF platforms
- Knowledge of DIA TMF Reference Model
- Familiarity with eCTD and CSR appendices
Why Join SMC Squared India?
At SMC Squared, people come first. As part of Hexaware Technologies, you’ll gain access to:
- A people-centric, inclusive work culture
- Global exposure in life sciences and technology projects
- Continuous professional growth and learning opportunities
- Hybrid work flexibility in Bengaluru North
How to Apply
