Key Responsibilities
• 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.