Analyst - Computer Software Validation (Remote)

Veeva Systems, Inc.; Madison (WI); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company in Life Sciences Technology is looking for a software validation expert to support clinical trial software within their rapidly expanding SaaS environment. This role offers flexibility through a remote work policy and opportunities for career growth, alongside a comprehensive benefits package including health insurance and generous PTO.

Benefits

Comprehensive benefits package

Generous flexible PTO

Company-paid holidays

1% charitable giving program

Qualifications

• 1+ year of experience in computer software validation for clinical trial software.
• Working knowledge of the software development cycle.
• Familiarity with GCP Guidance, including 21 CFR Part 11.

Responsibilities

• Participate in requirement gathering sessions with clients and RTSM team members.
• Develop and maintain CSV deliverables such as specifications and test scripts.
• Manage validation testing cycles and address issues and enhancements.

Skills

Attention to detail

Interpersonal skills

Communication

Tools

Selenium

Microsoft Word

Microsoft Excel

Job description

Employer Industry: Life Sciences Technology

Why consider this job opportunity:
- Salary up to $100,000
- Opportunity for career advancement and growth within a rapidly expanding SaaS company
- Work remotely with Veeva's Work Anywhere policy, providing flexibility to work from home or in the office
- Comprehensive benefits package including medical, dental, vision, and life insurance
- Generous flexible PTO and company-paid holidays
- Commitment to community through a 1% charitable giving program

What to Expect (Job Responsibilities):
- Participate in requirement gathering sessions with clients and RTSM team members
- Collaborate with RTSM Development and Project Management teams to define clear, testable, and compliant requirements
- Develop and maintain CSV deliverables such as specifications, test scripts, and summary reports
- Manage validation testing cycles and address issues and enhancement requests
- Provide technical expertise in computer system validation and support customers in RTSM validation activities

What is Required (Qualifications):
- 1+ year of experience in computer software validation for clinical trial software (CTMS, CDMS, eTMF, etc.)
- Working knowledge of the software development cycle (SDLC)
- Familiarity with GCP Guidance, including 21 CFR Part 11 and EU Annex 11
- Exceptional attention to detail and good interpersonal skills
- Proficiency in English communication with diverse team members and customers

How to Stand Out (Preferred Qualifications):
- Familiarity with the conduct of clinical trials
- Previous experience with RTSM systems
- Expertise in Microsoft Word and Excel
- Experience with authoring automation testing using Selenium

#LifeSciences #SoftwareValidation #RemoteWork #CareerGrowth #SaaS

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