External Data Management Senior Specialist

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From MSD’s original posting

Job Description The External Data Management Senior Specialist leads trial-level external data strategy and delivery studies. The role owns transfer-spec development, monitors transfers through conduct and lock, drives defect triage and resolution, ensures regulatory/SOP (Standard Operating Procedure) compliance and data readiness, and mentors junior analysts while reporting metrics and lessons learned. They also support the CDM Trial Lead in trial-level data quality oversight and risk identification. Responsibilities • Gather external data requirements from protocols, service providers, and study teams. • Ensure external data specifications are developed, compliant with standards and approved by required stakeholders. • Verify that test and first production files conform to approved external data specifications. • Oversee external data file loading, review error logs, and drive resolution of data load issues. • Proactively support the CDM Trial Lead in trial-level data quality oversight and risk identification. • Lead or support Specimen Lifecycle Management reconciliation and external data validation activities to ensure data usability for CDM (Clinical Data Management) review…