Key Responsibilities

1. Perform clinical data management activities, including data cleaning, manual and system checks, and updating relevant trackers.
2. Manage data discrepancies, clinical queries, and issues, ensuring timely resolution and data accuracy.
3. Support database lock activities and ensure all required tasks are completed within agreed timelines.
4. Identify activities at risk of missing client SLAs and develop corrective action plans in coordination with the Team Lead (TL).
5. Maintain and archive essential study documentation and records in accordance with audit, quality, and information security requirements.
6. Ensure reliable and timely retrieval of clinical trial documentation and information for audit purposes.
7. Support multiple clinical trials across diverse therapeutic areas and contribute to their successful completion.
8.



Provide technical oversight and operational support for clinical data management activities whenever required.
9. Work with clinical data systems such as Medidata Rave and Veeva EDC.
10. Handle third-party vendor data, including laboratory, pharmacokinetic (PK), imaging, and other external clinical data.
11. Use Spotfire reporting tools for data review, tracking, and reporting activities.
12. Communicate effectively with clients and internal stakeholders to provide updates, resolve queries, and ensure smooth study delivery.

Valuable-to-Have Skills

Spotfire Reporting, Multiple Therapeutic Area Experience, Technical Oversight, Clinical Data Reporting, Vendor Data Reconciliation, Clinical Data Standards, Process Improvement.

📌 SPE-Clinical Data Management (Pune)
🏢 Cognizant Technology Solutions India
📍 Pune