TCS is hiring for ETMF Specialist Role !!!

Location - Mumbai / Pune

Experience - 1 to 3 years

Job Description:

1. The eTMF Document Specialist will collaborate with the eTMF Team Lead, to ensure Trial Master File (TMF) business needs are addressed in a proactive and timely manner.

2. Act as a document creator / QCer / primary contact for all issues related to TMF processing and inspection readiness.

3. Provide input to the management of the TMF processes as it relates to the Document Specialist interfaces.

4. Collaborate with the eTMF Team Lead in order to ensure alignment of processes across all Functions

5. Deliver quality control measures and communication of relevant TMF issues / challenges to the Sr. eTMF Document Specialist as the first line. Followed by the eTMF Team Lead and eTMF Group Lead.

6. Provide input into functional SOPs, guidelines, and system user guides as related to the accuracy and completeness of TMF.

7. Perform discrepancy management in accordance with the process guidelines and timelines.

8. Provide support during internal and external inspections by regulatory bodies.

Best Regards,

Megha Dixit - TCS HR