Computer Software Validation Analyst (Remote)
veeva · North Carolina - Raleigh
Job description
About the role
Veeva Systems is seeking a Computer Software Validation (CSV) professional specialized in clinical trial software to join the Randomization and Trial Supply Management (RTSM) team. You will own the validation process for assigned projects, ensuring product excellence and helping customers bring treatments to patients faster. The role is fully remote under Veeva’s Work Anywhere policy.
Key responsibilities
- Participate in RTSM requirement gathering sessions with clients and team members.
- Collaborate with Development and Project Management to define clear, testable, compliant requirements.
- Develop and maintain CSV deliverables such as specifications, test scripts, summary reports, and trace matrices.
- Manage validation testing cycles, resolve issues, and handle enhancement requests.
Required profile
- 1+ year experience in CSV for clinical trial software (CTMS, CDMS, eTMF, etc.).
- Working knowledge of the software development life cycle (SDLC).
- Familiarity with GCP guidance, 21 CFR Part 11, and EU Annex 11.
- Exceptional attention to detail and strong interpersonal communication in English.
Required skills
- Expertise in Microsoft Word.
- Expertise in Microsoft Excel.
- Familiarity with the conduct of clinical trials.
- Previous experience with Randomization and Trial Supply Management (RTSM) systems.
What we offer
- Medical, dental, vision, and basic life insurance.
- Flexible PTO and company‑paid holidays.
- Retirement programs.
- 1% charitable giving program.
- Base salary $60,000‑$100,000, with potential bonus and stock options.
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Published 1 day ago
Expires 1 month from now
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veeva
North Carolina - Raleigh
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