Remote Analyst, Computer Software Validation

Summary

Join Veeva Systems, a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As a Computer Software Validation (CSV) professional with a specialty in clinical trial software, you will work on leading solutions in Randomization and Trial Supply Management (RTSM) software, supporting customer implementations and taking ownership of the validation process for assigned projects.

Requirements

• 1+ year of experience in a 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
• Experience with authoring automation testing using Selenium

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

Benefits

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