Lead Data Manager

Role: Lead Data Manager

Location: Mumbai/Pune

Band: BPO4/5/6

Salary Range: 11 - 20 LPA

Shift: General Shift

Experience in leading clinical studies. Study Conduct and Close Out

Job Description

1. Possesses full understanding of EDC, study documentation, including the protocol, to perform proper execution of data management activities with full oversight and accountability for more

than one trial.

2. In-depth knowledge of the protocol, clinical drug development processes, guidelines regarding data management of clinical trials is required. Should possess relevant system/technical knowledge. In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) is required. Knowledge of technology platforms, confidentiality for data exchange, and project management and techniques is required.

3. Able to contribute to Operational topics, i.e. Support development of trial specific documents like e.g., clinical trial protocol, be part of the trial team and attend operational meetings.

4. Primary point of contact for POC for trial related discussions.

5. Able to develop mock CRFs for EDC Build, release and amend database, prepare data transmission agreements, maintain study in EDC system and prepare Trial-specific Instructions for CRF Completion required for Data collection systems.

6. Create data management and data review plan, prepare data validation specifications, managing queries, perform SAE reconciliation as well as external vendor reconciliations and further support the development of CQM plan as a part of Data Review and Clinical Quality Monitoring activities.

7. Supporting in execution of data listings programs for patient data consistency, quality and completeness.

8. Set-up and test SDTM specifications, decide for regular SDTM transformation runs, perform study data snapshots creation requests, create define xml alongside the SDTM programmers.

9. Should deliver adhoc, planned interim or final data and handle data after final data delivery.

10. Upload and approve all the required trial documentation in the trial master file regularly.

11. Highlight risks and issues to Project Lead on timely basis.

12. Provide oversight and perform QC of end-to-end data collection for the trial.

13. Provides trial metrics, resolve study issues, keep a track of all deliverables within agreed timelines thus ensuring error free quality data with no open queries before database lock.

14. Guides the new team members on the trial, on trial documents and during training stages.

15. Ensures compliance of team with all relevant TCS SOP's and documentation requirement of staff trainings.

16. Provide technical expertise to trial team members as appropriate in upkeeping the stability of the trial requirements.

17. Responsible for training the Data Management team on specific processes, procedures and applications.

18. Any other tasks deemed appropriate.

19. Complete assigned LOS trainings on time.

20. Required Competency: Leadership, proactive communication skills, risk management, negotiation skills, planning and prioritizing, analytical abilities.