Validation Analyst – Randomization & Trial Supply Management

About the role

We are looking for a Computer Software Validation (CSV) professional with a specialty in clinical trial software to join our Randomization and Trial Supply Management (RTSM) team. In this role you will own the validation process for assigned projects, work closely with development and project‑management teams, and help ensure the RTSM system meets regulatory and quality standards.

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.
• Apply a risk‑based approach to verify that requirements are adequately tested.
• Develop and maintain CSV deliverables such as requirement specifications, test scripts, summary reports, and traceability matrices.
• Manage validation testing cycles, track issues, and coordinate resolution of enhancement requests.
• Maintain change‑control documentation to ensure ongoing validation of the RTSM system.
• Provide technical expertise on computer‑system validation, applicable regulations, and quality‑system requirements to RTSM team members.
• Support customers as needed during RTSM validation activities.

Required profile

• Working knowledge of the software development life‑cycle (SDLC).
• Exceptional attention to detail.
• Strong interpersonal skills and ability to communicate in English with team members and customers of varying roles and skill levels.

Required skills

• Software Development Life Cycle (SDLC)
• Computer System Validation (CSV)