Veeva Systems
Analyst - Computer Software Validation (Remote)
$60K–$100K
North Carolina - Raleigh · Remote · Full-time · Posted Feb 1, 2022
- Experience
- 1+ year in CSV for clinical trial software.
About the job
Own and support computer software validation for customer implementations of Veeva’s Randomization and Trial Supply Management (RTSM) clinical trial software.
What you'll do
- Gather and clarify client requirements, ensuring they are testable and compliant.
- Create and maintain validation documentation, including specifications, test scripts, reports, and trace matrices.
- Manage validation testing, issue resolution, change control, and customer validation support.
What they ask for
- At least 1 year of CSV experience with clinical trial software (CTMS, CDMS, eTMF, etc.).
- Working knowledge of the software development cycle (SDLC).
- Working knowledge of GCP guidance, including 21 CFR Part 11 and EU Annex 11.
- Strong attention to detail and ability to communicate in English with colleagues and customers.
Nice to have
- Familiarity with clinical trials or prior RTSM experience.
- Expertise in Microsoft Word and Excel.
Pay
USD 60,000 - $100,000 base salary
Tools
RTSM, CTMS, CDMS, eTMF, SDLC, 21 CFR Part 11, EU Annex 11, Microsoft Word
Model-written summary · the original posting is authoritative