External Data Management Senior Specialist

MerckPOL - Mazowieckie Wojewodztwo - Warsaw (Trade Center)onsiteSalary not postedView the original posting at Merck ↗

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 and database lock. Lead and participate in service provider forums (e.g., kick-off meetings, routine status meetings). Oversee service provider KPIs, SLAs (Service Level Agreements), metrics, and adherence to timelines; identify and escalate risks to study leadership as needed. Prepare and present required service provider performance metrics to management, relationship management, and governance forums. Support QA (Quality Assurance) activities related to service provider qualification, audits, and CAPA resolution. Act as a reliable partner to GDMS (Global Data Management & Standards), IT, and other cross-functional teams, aligning priorities and closing feedback loops. Collaborate with IT to troubleshoot and resolve complex platform or integration issues, escalating high-impact risks appropriately. Mentor junior analysts on tools, checks, and service provider interactions. Lead trial-level service provider management activities, including performance trending and issue/risk reviews. Lead or participate in team meetings, providing clear status and feedback on assigned checks and reconciliations. Contribute expertise, project management, and/or leadership to additional projects and continuous improvement initiatives, including (but not limited to) process, standards, and platform / tool efforts. Maintain compliance with SOPs (Standard Operating Procedures), ICH-GCP (International Council for Harmonization - Good Clinical Practice), and protocol-specific processes. Archive required documentation in the eTMF (electronic Trial Master File), including service provider correspondence, mapping specifications, and transfer logs, to ensure traceability and inspection readiness. Technical skills Working understanding the clinical development process and trial data flow. Proficiency with electronic data capture (EDC) platforms, other data acquisition tools (e.g. eCOA [electronic Clinical Outcomes Assessment]) and external data integrations, including authoring edit check and reconciliation specifications (and/or programming where applicable). Deep knowledge of appropriate standards and terminology; partners effectively with Standards on new terms and updates. Experience preparing complete, well-organized documentation for audits and inspections. Advanced authoring and maintenance of external data specifications with clear implementation guidance for service providers and IT; manages versioning and change control. Deep experience executing reconciliation (cross-system completeness and consistency), end-to-end (E2E) data lineage and traceability, and reference-range or clinical plausibility checks to ensure accurate, audit-ready external data. Proven RCA of load and mapping defects; defines corrective actions and contributes to UAT (User Acceptance Training) for external data

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