Analyst - Computer Software Validation

Veeva is a mission-driven organization that aspires to help our customers in Life Sciences and Regulated industries bring their products to market, faster. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, and Speed. Our teams develop transformative cloud software, services, consulting, and data to make our customers more efficient and effective in everything they do. Veeva is a work anywhere company. You can work at home, at a customer site, or in an office on any given day. As a Public Benefit Corporation , you will also work for a company focused on making a positive impact on its customers, employees, and communities. The Role: 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 #RemoteCroatia Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. 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. Apply for this job