Remote Validation Analyst

Summary

Join us in transforming the life sciences industry as a Computer Software Validation (CSV) professional with a specialty in clinical trial software. This role will give you the opportunity to work on a leading solution in Randomization and Trial Supply Management (RTSM) software, utilizing your expertise to take ownership of the validation process for assigned projects and play an important role in building and maintaining product excellence for the RTSM system.

Requirements

• 1+ years of experience in a CSV for software
• Working knowledge of software development cycle (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

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