Clinical Data Lead Jobs

Study Delivery

1. Provides support and training on the Clinical data management activities to TCS Data Managers for the relevant functional processes/work statements/projects - be trained and perform as back up where required

2. Maintains & builds awareness of internal and external clinical Data Management practices to enhance domain expertise

3. Single point of contact for Study Data Manager / designee

Study /Project Management

4. Overall in-charge of all Data Management activities for a study/ies including Study Set up, Conduct and Close Out.

5. Primary point of contact for CDM and works are liaison for CP, DAS and CCS activities too

6. Monitors and evaluates overall study progress, identify the potential risk / challenges faced during the course of the study

7. Conducts regular team meetings for study updates and provides guidance on study related issues to TCS internal teams

8. Monitor, maintain & report KPI / SLAs /metrics on the study

9. Performs tasks/activities as communicated by the TCS Group Leader (GL) and / or Project Manager (PM) and Study Data Manager (SDM)

10. Ensures adequate resource for the Study throughout its lifecycle in collaboration with Group leader and informs (SDM and/or Alliance Manager (AM) as applicable) contact of any changes in staff

11. Keeps TCS Group Lead & Project Manager fully informed about the need for the resources so the resource requests can be finalized with AM and TCS PM

12. Keeps record of all activities to ensure the smooth flow of the study throughout its lifecycle

13. Set priorities and targets of the study within the CP, DM, CCS, DAS teams

14. Responsible for recruitment, selection, training of team members & managing attrition

15. Works as mentor for DM staff assigned on the study/ies

Training & Communication

16. Provide regular status reports to TCS Group Lead and Study Data Manager (SDM)

17. Proactively communicate / escalate the identified unresolved issues/challenges to TCS Group Lead and / or Project Manager and Alliance manager / Study Data Manager (SDM)

18. Communicate between different stakeholders and Study Data Manager (SDM)

19. Identify training needs for team members and maintains documents of staff training assessments including updates.

20. Actively contributing in creation of Investigator Meeting slides and attending the SMT meetings

Quality

21. Ensure the team members deliver high quality work and follow effective Data Management processes within the function

22. Ensures compliance of the team with all relevant TCS SOPs and all documentation requirement of staff training / assessments

People

23. Responsible for ongoing monitoring & development of study team at functional level

24. Assist Group lead in recruitment and selection of the team members from a domain technical evaluation perspective

25. Responsible for assessing the performance of Data Managers and reporting the progress to TCS Group Lead

Skills Required

26. Excellent Technical skills, start-up knowledge is must

27. Excellent verbal and written skills, good organizational, interpersonal, and team skills

28. Project management & result orientation

29. Excellent Planning and Organizing skills

30. Strong knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology

Other:

31. Ability to work on multiple database set-up, locks, data review, cleaning, coding, SAE reconciliation, and some CRO or vendor interface

32. Knowledge of PL/SQL is not required, but will serve as a recommendation

“All offers of employment extended to applicants will be conditional and will require, among other things, that the recipient of the offer of employment submit proof that s/he is fully vaccinated at that time or will submit such proof prior to determining a start date . Individuals with medical issues or sincere religious beliefs that prevent them from getting the vaccine may request an exemption from the vaccine requirement. To the extent State legislation or executive action purports to limit TCS’s ability to require vaccination for individuals who object on a basis other than medical issues or sincere religious beliefs, individual requests for an exception to TCS’s generally applicable vaccination policy pursuant to relevant State regulation will be evaluated on a case-by-case basis. Individuals who receive an exemption from vaccination for any reason may be required to comply with other Covid precautions. “