Senior External Data Management Lead for Clinical Trials

MSD Polska; Województwo mazowieckie; Vor Ort; PLN 260.000 - 360.000; Vollzeit

Zusammenfassung

Merck & Co., Inc. in Poland seeks an External Data Management Senior Specialist to lead trial-level external data strategy and delivery studies.

You will own transfer-spec development, monitor data transfers, drive defect triage, ensure regulatory/SOP compliance, and mentor junior analysts while reporting metrics and lessons learned. You will support the CDM Trial Lead in data quality oversight, risk identification, and collaboration with GDMS, IT, and cross-functional teams to close feedback

Qualifikationen

• Experience in clinical data management and data management.
• Proficient English communication skills.
• Strong stakeholder and vendor management abilities.

Aufgaben

• Gather external data requirements from protocols, service providers, and study teams.
• Ensure external data specifications are developed and approved by stakeholders.
• Verify test and first production files conform to specifications.
• Oversee external data file loading and resolve data load issues.
• Support CDM Trial Lead in data quality oversight and risk identification.
• Lead reconciliation and validation activities for data usability in CDM review.
• Lead or participate in service provider forums and KPI reviews.
• Present service provider performance metrics to management and governance forums.
• Support QA activities related to service provider qualification and CAPA resolution.
• Collaborate with GDMS, IT, and cross-functional teams to align priorities.

Kenntnisse

Clinical Data Management

Data Management

English Language

Stakeholder Management

Vendor Management

Ausbildung

Associate's Degree

Bachelor's Degree

Advanced Degree (Masters/Doctorate)

Jobbeschreibung

Merck & Co., Inc. in Poland seeks an External Data Management Senior Specialist to lead trial-level external data strategy and delivery studies.

You will own transfer-spec development, monitor data transfers, drive defect triage, ensure regulatory/SOP compliance, and mentor junior analysts while reporting metrics and lessons learned. You will support the CDM Trial Lead in data quality oversight, risk identification, and collaboration with GDMS, IT, and cross-functional teams to close feedback