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 escape 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; managers 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 feeds. Trial-level metrics literacy (timeliness, completeness, defect rates) to target and verify improvements. Non-technical skills
Communicates effectively (oral and written) with technical and business partners and external service providers; translates technical topics for non-technical stakeholders and adapts style to audience. Manages difficult conversations constructively; negotiates timelines and quality expectations. Demonstrated ability to provide mentorship to junior team members. Demonstrated ability to lead day-to-day activities; drives issue triage to closure and coordinates stakeholders. Prioritizes independently; escalates with context, impact, and recommendation. Delivers crisp status, decisions, and blockers; maintains decision logs. Enterprise Leadership Skills
Networking & Partnerships | Develops and sustains productive relationships within and across functions to enable collaboration, alignment, and the achievement of shared goals. Executional Excellence | Dr
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External Data Management Senior Specialist in Warsaw – pracodawca: Merck
Merck w Polsce to doskonały pracodawca, który oferuje dynamiczne środowisko pracy w obszarze onkologii, gdzie innowacje i współpraca są na porządku dziennym. Nasza kultura pracy sprzyja rozwojowi zawodowemu, a pracownicy mają dostęp do licznych szkoleń oraz możliwości awansu. Dodatkowo, praca w Merck w Polsce to szansa na realny wpływ na poprawę dostępu pacjentów do nowoczesnych terapii w jednym z najważniejszych segmentów rynku zdrowia.
