Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day.
Post : R&D Project Leader I
Job Description
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. Review of the Study Protocol and Case Report Forms
6. Preparation and Review of Data Validation Specification (DVS).
7. Preparation and review of manual listing of the study, eCRF Completion guidelines,DMP
8. Create and review of the test scripts for the UAT (User Acceptance Testing)
9. Performing UAT of the edit checks and screens review of the study.
10. Performing the Data Management activities of the studies like query management which includes query generation and query resolution.
11. Performing external data reconciliations (SAE and Lab data).
12. Generating metric reports/study status reports for the DM status of the study and updating the stakeholders of the study.
13. Documentation of the study activities as per SOP and regulatory guidelines.
14. Freezing and Locking of the database.
15. Performing the Post production changes and assessing the impact for the changes.
Additional Information
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : R&D
End Date : 20th February, 2020
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