Analyst - Computer Software Validation (Remote)
North Carolina - Raleigh
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. 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
- 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. Apply
Job Profile
Basic life insurance Charitable giving Charitable giving program Company paid holidays Dental Dental Insurance Employee success Flexible PTO Growth potential Life Insurance Medical Medical, dental, vision, and basic life insurance Medical Insurance Paid holidays PTO Remote-first company Retirement programs Vision Vision Insurance Work anywhere Work From Home
Tasks- Collaborate with development and project management
- Develop and maintain CSV deliverables
- Ensure requirements are tested
- Manage validation testing cycles
- Participate in requirement gathering
- Project management
- Provide technical expertise
- Support customers
Attention to detail Automation Automation Testing Clinical trials Clinical trial software Cloud Computer software validation CTMS Customer Success Development Documentation ETMF Excel GCP GCP guidance Interpersonal Life sciences Microsoft Excel Microsoft Word Organization Project Management Quality Randomization and trial supply management Risk-based approach Risk-Based Testing SaaS SDLC Selenium Software Development Software Development Cycle Software development life cycle Software validation Technical Writing Test Scripts Validation Writing
Experience1 years
Education TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9