Computer Software Validation Analyst

Job is Expired
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Tue, Sep 05, 2023

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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