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Computer Software Validation Analyst
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
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COMPLETE JOB DESCRIPTION
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