External Data Management Specialist

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From MSD’s original posting

Job Description The External Data Management (EDM) Specialist supports teams in execution of trial-level external-data activities, authoring and maintaining transfer specifications and coordinating with service providers/IT for accurate ingestion. The role performs completeness, reconciliation, and traceability checks, applies standards and controlled terminology, and supports audit/inspection preparation and targeted process improvements. Responsibilities • Gather external data requirements from protocols, service providers, and study stakeholders. • Develop external data specifications in accordance with standards, obtaining required stakeholder approvals. • Execute test and first-production file reviews to confirm adherence to approved external data specifications. • Monitor external data file loads, review error logs, and resolve or escalate issues as appropriate. • Support Specimen Lifecycle Management reconciliation and external data validation to ensure data are review- and lock-ready for CDM (Clinical Data Management). • Participate in service provider governance forums (e.g., kick-off and status meetings). • Monitor service provider KPIs, metrics, and timelines; identify…