Subham Dutta

• Monitoring Management Associate (July 2024 - Present)

Tata Consultancy Services Pvt. Ltd.

1. Doing monitoring management activities for various servers and clusters through various tools (PSW, Coralogix, SolarWinds, JIRA, Natreo, etc.).

2. Providing live support to the acquirer/vendor.

3. Taking production calls and preparing slides.

4. Preparing daily health check reports and graphs also.

5. Real-time detection of anomalies, incidents, or failures.

6. Ensure changes are implemented as per schedule, and rollback plans are in place.

7. Monitor the deployment of new software, or infrastructure changes.

8. Validate system stability post-deployment.

• Clinical Data Reviewer (Nov 2021 - Jul 2024)

Tata Consultancy Services Pvt. Ltd.

1. Discrepancy Management, Generate Manual Queries, Actioning and Closing queries (Manual and Auto), or apply self-evident corrections to the data according to the relevant guidelines.

2. Develop and maintain good communications (meeting, mail, chat) and working relationships with site, CRA, monitor, secondary monitor, lab location, and supporting teams.

3. Action the queries/findings received from the Statisticians or Clinical Team.

4. CDB Listings, Manual Review

5. Doing PK reconciliation, IRT reconciliation, imaging reconciliation, ADA/Nab reconciliation, PPD reconciliation, and CRL reconciliation.

6. Lab Normal Entry, Review, and QC.

7. Missing form activity.

8. Protocol deviation creation activity and review complete activity.

9. Freezing activity, locking activity.

10. Preparing study metrics data (missing scan, missing follow-up report, query analysis, protocol deviation report, missing forms/pages report, SDV report, etc.) to send to the CRA every week.

11. Understand and comply with core operating procedures, working instructions, and meet objectives as assigned. 12. Archived the project reports and all project-related documents.

13. Plans the necessary activities to achieve milestones and deliverables according to the project plan.

14. Groom new team members.

15. Participated in the study's interim analysis.

16. Providing production support to the site.

17. Uploading different third-party issue logs for correction in the vendor portal on the EAP portal.

18. Adding outstanding queries on the RIM portal to resolve and update data correctly in the database.

19. Screen UAT of eCRF

20. Drafting a data review plan and testing the SAS listing as per the review plan.

21. Audit trail validation.

22. Drafting CRF completion guidelines.

23. Preparing the data manager's study status report and QDR KPI report.

• 1. Data entry for UAT purposes and quality check, reports UAT for different conditions.
• 2. Test Case Writing for Edit Checks.
• Generate and close queries, or apply self-evident corrections to the data according to the relevant guidelines and data review.
• 4. J-Review, Edit Check Listings.
• 5. ECG Reconciliation, PK Reconciliation, and IVRS Reconciliation.
• 6. Manual review and issue queries.
• 7. Worked in the Study Designing Group: edited check creation and added activity in Medidata RAVE.
• 8. Develop and maintain good communications (meeting, mail, chat) and working relationships with site, CRA, monitor, secondary monitor, lab location, and supporting teams.
• 9. Meet objectives as assigned.
• 10. To be aware of and updated on the client’s quality standards, and to undertake any relevant training for the same if required.
• 11. Worked on post-production changes, which involved writing new edit checks or modifying the existing checks to make them fire appropriately. Amending the Setup document to meet the protocol-specified criteria.