Validation Analyst – Randomization & Trial Supply Management (RTSM)

About the role

We are seeking a Computer Software Validation (CSV) professional with a focus on clinical‑trial software to join our Randomization and Trial Supply Management (RTSM) team. The role offers the chance to work on a leading RTSM solution, applying strong technical writing skills to simplify complex validation topics.

Key responsibilities

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

Required profile

• Exceptional attention to detail.
• Strong interpersonal skills and ability to communicate effectively in English with diverse stakeholders.

Required skills

• Working knowledge of the Software Development Life Cycle (SDLC).
• Experience with Computer Software Validation (CSV) processes.
• Familiarity with GCP guidance, including 21 CFR Part 11 and EU Annex 11 (nice to have).