External Data Management Senior Specialist

Merck; Województwo mazowieckie; On-site; PLN 180,000 - 260,000; Full time

Job summary

Merck is seeking an External Data Management Senior Specialist to lead trial-level external data strategy and delivery. The role owns transfer-spec development, monitors transfers, drives defect triage, ensures regulatory compliance, and mentors junior analysts.

You will report metrics and help GPDM quality oversight and risk identification. You will collaborate with GDMS, IT, and cross-functional teams to close feedback loops, escalate high-impact risks, and ensure data readiness for database

Qualifications

• Experience leading external data strategy for trials in CDM.
• Proven ability to author external data specifications and data transfers.
• Knowledge of ICH-GCP, SOPs and clinical trial data flow.
• Strong documentation, audit readiness, and issue resolution skills.

Responsibilities

• Gather external data requirements from protocols, providers, and study teams.
• Develop external data specifications and obtain stakeholder approvals.
• Verify test and production files meet external data specs.
• Oversee external data file loading and resolve data load issues.
• Support data quality oversight and risk identification for trials.
• Lead reconciliation and validation activities for data usability.
• Lead service provider forums and monitor KPIs/SLAs.
• Present performance metrics to management and governance forums.
• Support QA activities related to provider qualification and CAPA.
• Collaborate with GDMS, IT and cross-functional teams to align priorities.
• Troubleshoot platform or integration issues with IT and escalate risks.
• Mentor junior analysts on tools, checks, and provider interactions.
• Lead trial-level service provider management and trend analysis.
• Contribute to continuous improvement in processes and standards.
• Maintain SOPs compliance and archive documents in eTMF for traceability.

Skills

External data management

CDM processes

EDC platforms

Data governance

Stakeholder communication

Data quality oversight

Job description

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