Company: Tata Consultancy Services (TCS)
Location: Mumbai, Pune, Bangalore, Indore, Ahmedabad
Employment Type: Full-time
Experience Level: Open
Job Responsibilities:
As a Clinical Data Management Specialist, you will:
- Undertake relevant training on GSK SOPs, GUI, and data standards.
- Understand study protocols, tasks, activities, and milestones.
- Review Data Validation Specifications (DVS), eCRF screens, and test scripts for edit/SAS checks.
- Create test scripts for UAT and manage study-specific tasks.
- Perform data review and discrepancy management.
- Process and deliver external (vendor) data using GSK tools.
- Conduct vendor data reconciliation to maintain database consistency.
- Escalate unresolved data discrepancies to the relevant team members.
- Coordinate with programming teams regarding database changes.
- Create and distribute data management metrics, listings, and reports.
- Conduct regular study meetings with the study team.
- Monitor vendor activities to address study issues.
- Perform close-out activities and ensure quality data delivery as per the Data Management Plan (DMP).
- Conduct Post Database Release (DBR) and Pre Database Freeze (DBF) activities.
- Maintain and archive study documents in the eTMF.
Qualifications:
- Graduate/Postgraduate degree in Life Sciences or Pharmacy.
Key Skills:
- Knowledge of GSK SOPs and GUI.
- Experience in clinical data validation and discrepancy management.
- Proficiency in tools used for external data reconciliation and clinical database management.
- Ability to communicate effectively and collaborate with diverse teams.
How to Apply:
If you meet the qualifications and are interested in this role:
- Share your CV with Megha Dixit at megha.dixit3@tcs.com
- Application Link