Veeva Systems

Compensation

Full Description

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