Validation Analyst/Senior Validation Analyst, Clinical Research
Core
Lead computerized system validation (CSV) for regulated digital and AI applications throughout the software development lifecycle (SDLC) to ensure quality, compliance, and patient safety in clinical research.
Role type
Senior Validation Analyst (Clinical Research)
Builds
Validated software applications and digital/AI products for pharmaceutical, biotechnology, and medical device organizations
Domain
Clinical Research / Life Sciences / Regulated IT
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Computerized System Validation (CSV) principles, GxP regulations (FDA 21 CFR Part 11, GAMP 5, ALCOA+), Risk-based validation methodologies, SDLC methodologies (Agile/Waterfall), Validation documentation (IQ/OQ/PQ, traceability matrices), Change control management, Root cause analysis
Preferred skills
Cloud-based or SaaS application validation, Clinical trial systems (CTMS, eTMF, EDC, LIMS), Project management tools (Jira, Azure DevOps, HP ALM), Regulatory inspection participation
Technologies
Jira, Azure DevOps, HP ALM, Microsoft Office (Excel, Word, PowerPoint, Project)
Responsibilities
Lead CSV activities for regulated digital and AI applications, Develop and execute validation deliverables (plans, risk assessments, test scripts, reports), Partner with cross-functional teams to ensure regulatory compliance, Review software requirements and change controls, Design and document risk-based testing strategies, Support system implementations and upgrades, Investigate test failures and resolve issues, Participate in internal and regulatory audits
Seniority
Senior, hands-on IC