- Perform clinical trial data review, query management, and data cleaning as per SOPs and study plans.
- Review and reconcile EDC, eCOA/ePRO and external/vendor data; coordinate with CROs, vendors, and study teams to resolve data issues.
- Perform SAE reconciliation and coordinate with Safety teams for issue resolution.
- Support preparation/maintenance of Data Cleaning Plans, Data Validation Plans/edit checks, data transfer/integration specifications, reconciliation plans, coding guidelines, and database lock plans.
- Support interim and final database locks.
- Support setup and testing of clinical data collection systems such as EDC, IRT, eCOA and ePRO.
- Maintain study documentation in eTMF, conduct QC reviews, support data archival and inspection-readiness activities.
- Monitor data-management metrics and escalate issues where required.
- Perform quality review of CRO activities and coordinate/mentor other Data Coordinators.
- Ensure compliance with SOPs, GxP and applicable regulatory requirements.