SPE-Clinical Data Management

Key Responsibilities

1. Carry out clinical data management tasks, including data cleaning, conducting manual and system validations, and updating relevant trackers.
2. Oversee clinical data discrepancies, clinical queries, and related issues, ensuring timely resolution and ongoing data accuracy.
3. Assist with database lock activities and verify that all required tasks are completed within agreed timelines.
4. Detect activities that may be at risk of missing client SLAs and formulate corrective action plans in collaboration with the Team Lead (TL).
5. Maintain, archive, and manage essential study documentation and records in alignment with audit, quality, and information security requirements.
6. Ensure dependable and timely access to clinical trial documentation and information to support audit needs.
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 as and when required.
9. Work with clinical data systems including Medidata Rave and Veeva EDC.
10. Manage third-party vendor data, including laboratory, pharmacokinetic (PK), imaging, and other external clinical data.
11. Utilize Spotfire reporting tools to support data review, tracking, and reporting activities.
12. Communicate clearly with clients and internal stakeholders to share updates, address queries, and help ensure smooth study delivery.

Good-to-Have Skills

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