Validation Analyst
Core
Validate software and clinical trial processes to ensure compliance with GCPs and SDLC standards.
Role type
mid-level IC validation analyst
Builds
validated software systems and compliant clinical trial operational processes
Domain
life sciences / clinical trials / software validation
Required skills
GCPs knowledge, SDLC understanding, software defect analysis, Microsoft Office Suite, test plan review, multi-disciplinary team coordination
Preferred skills
ability to teach others, troubleshooting, time management, adaptability
Technologies
Microsoft Office Suite (Word, Excel, PowerPoint, Project), in-house and off-the-shelf computer software
Responsibilities
Review and critique SDLC documentation including requirements, functional design, system design, and test plans; analyze software defects and assess causes of test failures; coordinate project activities on a multi-disciplinary team; apply knowledge of GCPs, SOPs, and process maps.
Seniority
Mid-level, hands-on IC