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