External Data Management Specialist

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

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 and communicate risks to study leads. Support our company’s Research Laboratory Quality Assurance in service provider qualification activities, audits, and CAPA resolution as required. Provide status updates on assigned checks and reconciliations in internal and external team meetings. Act as a reliable partner to GDMS (Global Data Management & Standards) and cross-functional teams, aligning on priorities and closing feedback loops to support coordinated delivery. Proactively support the CDM Trial Lead in trial data quality oversight and risk identification. Support additional projects and continuous improvement initiatives as assigned, including (but not limited to) process, standards, and platform / tool efforts. Archive and maintain required external data documentation in the eTMF (electronic Trial Master File) per SOPs (Standard Operating Procedures), including service provider correspondence, mapping specifications, and transfer logs. Maintain compliance with SOPs, ICH-GCP (International Council for Harmonization - Good Clinical Practice), and protocol-specific requirements to ensure inspection readiness. Required technical skills Working understanding of the clinical development process and end-to-end trial data flow. Working knowledge of clinical trial data structures and tools, including electronic data capture (EDC) and other data acquisition tools (e.g. eCOA [electronic Clinical Outcomes Assessment]) as well as associated utilities for managing, extracting, and reporting data. Able to interpret mapping rules, review load logs, and recognize common data-integration defect patterns. Basic knowledge of standards-library processes and working experience applying CDISC [Clinical Data Interchange Standards Consortium] (SDTM [Study Data Tabulation Model], CDASH [Clinical Data Acquisition Standards Harmonization]) and controlled vocabularies (e.g., LOINC [Logical Observation Identifiers Names and Codes]) Required non-technical skills Communicates effectively (oral/written) with technical and business partners and electronic data providers; adapts style to audience. Collaborates effectively across functions; facilitates small working sessions and follows through on action items. Works independently with minimal guidance; proactively identifies risks and proposes options. Manages multiple tasks and priorities while maintaining focus on the critical path. Uses data and basic structured thinking to triage issues, document assumptions and decisions, and escalate appropriately. Required Enterprise Leadership Skills Networking & Partnerships | Develops effective working relationships across teams to support collaboration, coordinate activities, and achieve shared goals. Executional Excellence | Takes timely action to accomplish work goals in line with compliance standar

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