Clinical Data Management Specialist

TCS is Hiring for Clinical Data Management role

Location - Mumbai / Bangalore / Pune / Hyderabad

Experience Range - 2 to 5

Preferred Educational Qualification for the role - Graduate / Postgraduate (Any life-science / Engineering)

Skill : Relevant experience in Clinical Trial study, conduct activities (Query Management, Tracking, Vendor data management, Data Validation etc.)

Job Description

1. Review and understand the study protocol and the timelines.

2. Perform data review, data reconciliation and query management tasks. Escalate / Action discrepancy in the clinical data as appropriate.

3. Implement study team feedback as required on the data.

4. Perform external checks to handle manual discrepancies and action the same.

5. Develop specifications, implementation and testing for the edit checks and listings (DVS)

6. Perform UAT for database

7. Develop study specific procedures documents

8. Ensure effective implementation of standard metric and status reporting on the study

9. Ensure an error free, quality data with no open queries.

10. Maintain data management study files and documentation

11. Attend and provide an update for data management services at cross-functional study team meetings both internally and with the sponsor

12. Identify out of scope tasks and bring to the attention of the TDM

13. Assist the TDM in all study set up activities.

14. Provide all study related reports to the TDM as per the request.

15. Perform SAE reconciliation and Vendor data reconciliation

16. Any other tasks deemed appropriate

Interested candidates who is having relevant Experience only, are requested share updated CV with below details on the mail id s.laharika@tcs.com

Regards

Laharika - TCS HR