1+ year of experience in Computer Software Validation (CSV) for clinical trial software.
Working knowledge of software development cycle (SDLC) and GCP Guidance such as 21 CFR Part 11, EU Annex 11.
Exceptional attention to detail and good interpersonal skills.
Proficiency in Microsoft Word and Excel is a plus.
Requirements:
Participate in RTSM requirement gathering sessions with clients and team members.
Collaborate with Development and Project Management teams to define clear and compliant requirements.
Develop and maintain CSV deliverables including test scripts and summary reports.
Manage validation testing cycles and provide technical expertise in computer system validation.
Job description
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.
We are looking for a Computer Software Validation (CSV) professional with a specialty in clinical trial software. This role would give you the opportunity to work on a leading solution in Randomization and Trial Supply Management (RTSM) software. To excel in this role, 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. You will use 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.
This is a remote role with Veeva’s Work Anywhere policy, allowing you to work in an office or at home on any given day. It’s about getting the work done in the way and place that works best for each person.
What You'll Do
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
Nice to Have
Familiarity with the conduct of clinical trials
Previous experience with RTSM
Expert in Microsoft Word and Excel
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Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
As an equal opportunity employer, Veeva is committed to fostering a culture of inclusion and growing a diverse workforce. Diversity makes us stronger. It comes in many forms. Gender, race, ethnicity, religion, politics, sexual orientation, age, disability and life experience shape us all into unique individuals. We value people for the individuals they are and the contributions they can bring to our teams.
If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com.
