Analyst - Computer Software Validation (Remote)

About the position

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

Responsibilities

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

Requirements

  • 1+ year of experience in a CSV for clinical trial software (CTMS, CDMS, eTMF, etc.)
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  • Working knowledge of software development cycle (SDLC)
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  • Working knowledge of GCP Guidance such as 21 CFR Part 11, EU Annex 11
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  • Exceptional attention to detail
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  • Good interpersonal skills and ability to communicate in English with team members and customers of varying roles and skill levels
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  • Experience with authoring automation testing using Selenium

Nice-to-haves

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

Benefits

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