Senior External Data Manager - Clinical Trials

MSD; Warszawa; Hybrid; PLN 180,000 - 240,000; Full time

Job summary

MSD is seeking an External Data Management Senior Specialist to lead trial-level external data strategy and delivery. You will develop transfer specifications, ensure regulatory compliance, and mentor junior analysts while tracking KPIs and SLAs.

You will collaborate with CDM, IT, and cross-functional teams to maintain data integrity and drive timely data readiness for database lock. The role requires strong experience with external data specs, data reconciliation, audits, and coordinating with

Qualifications

• Minimum 8+ years in data management or a related field.
• Experience in clinical trial operations.
• Excellent communication and stakeholder management skills.

Responsibilities

• Gather external data requirements from protocols and study teams.
• Develop compliant external data specifications and obtain approvals.
• Verify test and first production files meet specifications.
• Lead service provider performance metrics and risk reviews.

Skills

Clinical Data Management

Data Management

English Language

Stakeholder Management

Vendor Management

Education

Bachelor's Degree in Life Sciences

Bachelor's Degree in Data / Information Technology

Advanced Degree (Masters or Doctorate)

Tools

EDC platforms

eCOA tools

External data integration tools

Job description

MSD is seeking an External Data Management Senior Specialist to lead trial-level external data strategy and delivery. You will develop transfer specifications, ensure regulatory compliance, and mentor junior analysts while tracking KPIs and SLAs.

You will collaborate with CDM, IT, and cross-functional teams to maintain data integrity and drive timely data readiness for database lock. The role requires strong experience with external data specs, data reconciliation, audits, and coordinating with