What are the responsibilities and job description for the Analyst - Computer Software Validation position at Veeva Systems?
State: WI
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.
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 and help our customers bring treatments to patients faster. To excel in this role you will require strong technical writing capabilities and the ability to simplify complex topics.
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
- Experience with authoring automation testing using Selenium
Nice to Have
- Familiarity with the conduct of clinical trials
- Previous experience with RTSM
- Expert in Microsoft Word and Excel
Perks & Benefits
- Medical, dental, vision, and basic life insurance
- Flexible PTO and company paid holidays
- Retirement programs
- 1% charitable giving program
Compensation
- Base pay: $60,000 - $100,000
- The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. 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.
Work Where It’s Best for You
Work Anywhere means you can 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. This applies across all locations and departments.
Work Anywhere does not mean work at any time. We have predictable core hours where employees are generally available for meetings and collaboration. Employees are focused and available during core hours.
We invest in our offices to make them places where our employees like to go. If you work in the office three or more days a week, you will have a dedicated office workspace. Our offices function as hubs to draw people in, create social bonds, and where random connections and mixing of ideas happen. We’re investing more in offices, culture, and offsite meetings, not less.
Product teams are organized in regional product hubs for optimal collaboration and live within a time zone of their hub. Our current product hubs are located in Pleasanton, Columbus, Boston, Kansas City, New York City, Raleigh, and Toronto. We create opportunities for teams to get together in person regularly.
Customer-facing roles, such as Sales and Professional Services, live near and/or travel to their customers.
When an employee moves within a country it does not cause a change in salary. Where you live impacts you and your family. Not knowing if your compensation will change if you move can cause stress and uncertainty for everyone. We wanted to eliminate that.
Work at Veeva. Work where it’s best for you.
Salary : $60,000 - $100,000
