Data Manager (Expert in Programming & developing EDC systems)
Core
Manage clinical trial data, validate EDC systems, and oversee database lock activities for pharmaceutical studies.
Role type
Mid-level clinical data manager (EDC systems expert)
Builds
Clinical trial databases and data quality reports for biopharmaceutical clients
Domain
Clinical research / Pharmaceutical data management
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
EDC system validation, SAS edit check validation, database testing, lab reference range management, serious adverse event reconciliation, data entry, medical coding, query resolution, report generation
Preferred skills
Experience with moderate to complex clinical trials, knowledge of database specifications and user acceptance testing
Technologies
EDC systems, SAS
Responsibilities
Perform validation of EDC systems and associated reports; Manage and create EDC user accounts; Update and maintain DM documentation; Enter data from trial documents; Manage entry, review, and tracking of lab reference ranges; Create and review study metric reports; Support database lock and close-out activities
Seniority
Mid-level, hands-on IC
