Validation Analyst/Senior Validation Analyst, Clinical Research

Discover Impactful Work

As a Senior Validation Analyst, you will play a critical role in the entire product development lifecycle by validating regulated computer systems used across the clinical research organization. You will partner with cross-functional teams to ensure software applications and digital/AI products meet regulatory requirements, business needs, and quality standards throughout the system development lifecycle (SDLC). You'll lead validation activities for new digital implementations, enhancements, and upgrades while supporting compliance with GxP regulations, company SOPs, and industry best practices. Familiarity with risk-based validation methodologies is a plus!

A Day in the Life

• Lead computerized system validation (CSV) activities for regulated digital and AI applications throughout the SDLC.
• Develop and execute validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ documentation (where applicable), test scripts, traceability matrices, and Validation Summary Reports.
• Partner with Business Analysts, Quality Assurance, IT, vendors, and project teams to ensure systems meet business and regulatory requirements.
• Review software requirements, functional specifications, design documentation, and change controls to ensure validation readiness.
• Design, execute, and document risk-based testing strategies that demonstrate systems perform as intended.
• Create and maintain validation evidence in accordance with internal procedures and regulatory expectations.
• Support system implementations, upgrades, patches, and application enhancements.
• Review and approve validation-related change controls and ensure ongoing compliance for validated systems.
• Investigate test failures, identify root causes, and collaborate with technical teams to resolve issues.
• Participate in internal audits, sponsor audits, and regulatory inspections by providing validation documentation and subject matter expertise.
• Contribute to continuous improvement initiatives that enhance validation processes, testing efficiency, and compliance.