Analyst - Computer Software Validation (Remote)

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 $3B 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.


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

Nice to Have

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

Interviewing with Veeva

We value your time and believe in a transparent hiring process. Here is the process you can expect.
  • Follow the application process and submit your resume.
  • Within 3 days, you will receive a link to a personality assessment administered by a third party.
  • Once you complete the assessment, our team will review your full application package and follow up via email with our decision.
  • If moving to the interview stage, the process is as follows:
    • A conversation with the hiring manager
    • A practical case exercise
    • A final conversation with our group's Senior Leader.
  • Once all interviews are complete, the manager will be in touch with a final decision.

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.
#LI-Remote
#LI-Associate

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

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