Clinical Data Validation & Compliance Specialist

Merck; Województwo mazowieckie; On-site; PLN 90,000 - 130,000; Full time

Job summary

Merck in Poland seeks a Business System Validation Specialist, GDMS Data Integration and Automation, to lead validation activities ensuring data integrity, regulatory compliance, and timely delivery of critical systems.

You will plan, execute, and document validation across studies, support audits, and collaborate with Product Owners, QA, and Engineering to drive continuous improvement in validation processes and evidence management.

Qualifications

• 4+ years in validation/testing role
• Experience with GxP and 21 CFR Part 11
• Experience with clinical data management systems
• Knowledge of SDLC and system validation
• Audits/inspections support experience

Responsibilities

• Execute standard and study-specific validation activities across systems per protocol and regulatory expectations
• Develop validation strategies and risk-based test coverage models for releases and milestones
• Maintain validation documentation (Test Plans, TRMs, Test Scripts, Defect Logs, Test Summaries)
• Monitor test execution, track defects, and coordinate issue resolution with cross-functional teams
• Contribute to RCA and CAPA for issues identified during testing
• Support internal and external audits/inspections with validation evidence

Skills

Data validation

Data integrity

Regulatory compliance

SDLC management

AI testing exposure

Education

Bachelor's degree

Associate's degree

Advanced degree (Masters or Doctorate)

Tools

Power BI

Job description

Merck in Poland seeks a Business System Validation Specialist, GDMS Data Integration and Automation, to lead validation activities ensuring data integrity, regulatory compliance, and timely delivery of critical systems.

You will plan, execute, and document validation across studies, support audits, and collaborate with Product Owners, QA, and Engineering to drive continuous improvement in validation processes and evidence management.