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Veeva Systems, a public benefit corporation and leader in industry cloud for life sciences, is seeking a Computer Software Validation (CSV) professional specializing in clinical trial software. This role focuses on Randomization and Trial Supply Management (RTSM) software, a leading solution in the clinical trials space.
You will work closely with Development and Project Management teams to support customer RTSM implementations. Your responsibilities include:
• Participate in RTSM requirement gathering sessions with clients and internal team members
• Collaborate with Development and Project Management to ensure requirements are clearly defined, testable, and compliant
• Ensure requirements are adequately tested using a risk-based approach
• Develop and maintain CSV deliverables including requirements specifications, test scripts, summary reports, and trace matrices
• Manage validation testing cycles and coordinate resolution of issues and enhancement requests
• Maintain change control documentation to ensure ongoing system validation
• Provide technical expertise to team members on computer system validation, applicable regulations, and quality system requirements
• Support customers in RTSM validation activities as needed
This is an opportunity to take ownership of the validation process for assigned projects and play an important role in maintaining product excellence for a critical clinical trial system. You will need strong technical writing capabilities and the ability to simplify complex topics for diverse audiences.
Veeva is a Work Anywhere company supporting flexibility to work from home or in the office. The company has offices in more than 15 countries and surpassed $3B in revenue in its last fiscal year.
REQUIREMENTS:
• Working knowledge of software development lifecycle (SDLC)
• Exceptional attention to detail
• Good interpersonal skills and ability to communicate in English with team members and customers of varying roles and skill levels
NICE TO HAVE:
• Working knowledge of GCP Guidance such as 21 CFR Part 11 and EU Annex 11
