Computer Software Validation Analyst

About the role

Veeva is seeking a Computer Software Validation Analyst to support its Randomization and Trial Supply Management (RTSM) solution for clinical trials. The role involves owning the validation process for assigned projects and ensuring product excellence in a fast‑paced, remote environment.

Key responsibilities

• Participate in RTSM requirement‑gathering sessions with clients and internal teams.
• Collaborate with Development and Project Management to define clear, testable, and compliant requirements.
• Develop and maintain CSV deliverables such as specifications, test scripts, summary reports, and traceability matrices.
• Manage validation testing cycles, resolve issues, and handle enhancement requests.
• Maintain change‑control documentation to keep the RTSM system continuously validated.
• Provide technical expertise on computer system validation, applicable regulations, and quality‑system requirements.
• Support customers in RTSM validation activities as needed.

Required profile

• At least 1 year of experience in computer software validation for clinical trial software (e.g., CTMS, CDMS, eTMF).
• Working knowledge of the software development life‑cycle (SDLC) and GCP guidance such as 21 CFR Part 11 and EU Annex 11.
• Exceptional attention to detail and strong interpersonal communication in English.

Required skills

• Microsoft Word
• Microsoft Excel

What we offer

• Total compensation range of €30,000 – €50,000 per year, potentially including variable bonus and stock awards.