Job Summary

A company is looking for a Computer Software Validation Analyst with a specialty in clinical trial software.

Key Responsibilities:

• Participate in RTSM requirement gathering sessions with clients and RTSM team members
• Closely collaborate with RTSM Development and Project Management teams to ensure requirements are defined in a clear, testable, and compliant format
• Develop and maintain CSV deliverables including requirements specifications, test scripts, summary reports, and trace matrices

Required Qualifications:

• 1+ year of experience in a CSV for clinical trial software (CTMS, CDMS, eTMF, etc.)
• Working knowledge of software development cycle (SDLC)
• Working knowledge of GCP Guidance such as 21 CFR Part 11, EU Annex 11
• Familiarity with the conduct of clinical trials
• Expert in Microsoft Word and Excel