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Analyst - Computer Software Validation (Remote)

extra holidays - extra parental leave - work from anywhere - fully flexible

Remote:

Full Remote

Contract:

Full time

Salary:

60 - 100K yearly

Experience:

Junior (1-2 years)

Work from:

Wisconsin (USA), United States

Offer summary

Qualifications:

1+ year of experience in CSV for clinical trial software, Working knowledge of the software development cycle, Knowledge of GCP Guidance like 21 CFR Part 11, Experience with authoring automation testing using Selenium, Expert in Microsoft Word and Excel.

Key responsabilities:

Participate in RTSM requirement gathering sessions
Collaborate with RTSM Development and Project Management teams
Ensure requirements are tested following a risk-based approach
Develop and maintain CSV deliverables like test scripts
Manage validation testing cycles and maintain change control documentation

Veeva Systems SME https://www.veeva.com/

5001 - 10000 Employees

See more Veeva Systems offers

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.

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.

#LI-Remote

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.