Clinical Database Management
Teva Pharmaceutical
Bangalore, IN
3d ago

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. 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.

Company Info

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.

We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.

We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.

This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Qualifications Function Research & Development Sub Function Biometrics Reports To In process of validation Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment.

It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

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