1. Overall responsiblity to carry the studies from Start-up to close-out.
2, Checking the team's quality deliverables and providing the quality metric to the reporting managers for continuous improvements.
3. Collaboration with cross geographical stakeholders and providing the inputs regarding the CDM activities carried out for the study assigned.
4. Assisting the team members in providing the automation ideas for smooth transistion of work.
5. Preparation and QC of eCRF specification of the team members.
6. Review of the Study Protocol and Case Report Forms
7 Preparation and Review of Data Validation Specification (DVS).
8 Preparation and review of manual listing of the study
9. Preparation and review of eCRF Completion guidelines
10. Preparation and review of Data Management Plan (DMP)
11. Create and review of the test scripts for the UAT (User Acceptance Testing)
12. Performing UAT of the edit checks and screens review of the study.
13. Performing the Data Management activities of the studies like query management which includes query generation and query resolution.
14. Performing external data reconciliations (SAE and Lab data).
15. Generating metric reports / study status reports for the DM status of the study and updating the stakeholders of the study.
16. Documentation of the study activities as per SOP and regulatory guidelines.
17. Freezing and Locking of the database.
18. Assisting team in all Data Management activities for the assigned studies and helping in other study UAT and close out activities when required.
19. Performing the Post production changes and assessing the impact for the changes.
20. Decision making capabilities in providing the DM related solution to the study team as applicable.
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