Analyst - Computer Software Validation (Remote)

About the role

We are looking for a Computer Software Validation (CSV) professional with a specialty in clinical trial software. This role offers the opportunity to work on a leading solution in Randomization and Trial Supply Management (RTSM) software, helping our customers bring treatments to patients faster. You will require strong technical writing capabilities and the ability to simplify complex topics. As a member of the RTSM team, you will work closely with Development and Project Management teams to support customer RTSM implementations in a fast-paced environment. This is a remote role with Veeva's Work Anywhere policy, allowing you to work in an office or at home.

Responsibilities

• Participate in RTSM requirement gathering sessions with clients and RTSM team members
• Closely collaborate with RTSM Development and Project Management teams to ensure requirements are defined in a clear, testable, and compliant format
• Ensure requirements are adequately tested following a risk-based approach
• Develop and maintain CSV deliverables including requirements specifications, test scripts, summary reports, and trace matrices
• Manage Validation testing cycles and resolution of issues and enhancement requests
• Maintain change control documentation to ensure ongoing validation of the RTSM system
• Provide technical expertise to RTSM team members in computer system validation, applicable regulations, and other quality system requirements
• Support customers as needed in RTSM validation activities

Requirements

• 1+ year of experience in CSV for clinical trial software (CTMS, CDMS, eTMF, etc.)
• Working knowledge of software development cycle (SDLC)
• Working knowledge of GCP Guidance such as 21 CFR Part 11, EU Annex 11
• 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

• Familiarity with the conduct of clinical trials
• Previous experience with RTSM
• Expert in Microsoft Word and Excel

Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program

Pay

Base pay: $60,000 - $100,000. The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Actual salaries may vary within the range above or below, depending on experience and location. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.