Analyst - Computer Software Validation
Core
Computer Software Validation (CSV) professional specializing in clinical trial software, focusing on Randomization and Trial Supply Management (RTSM) systems.
Role type
Computer Software Validation Analyst
Builds
RTSM software solutions for life sciences companies
Domain
Life Sciences / Clinical Trials / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CSV for clinical trial software, SDLC knowledge, GCP Guidance (21 CFR Part 11, EU Annex 11), technical writing, risk-based testing, change control documentation
Preferred skills
Clinical trial conduct knowledge, RTSM experience, Microsoft Word/Excel expertise
Responsibilities
Participate in requirement gathering sessions, collaborate with development teams to define compliant requirements, ensure requirements are tested via risk-based approach, develop and maintain CSV deliverables, manage validation testing cycles, maintain change control documentation, provide technical expertise on CSV and regulations, support customers in validation activities
Seniority
Junior to Mid-level, hands-on IC