Remote CSV Analyst - Clinical Trial Software Validation

Veeva Systems; Raleigh (NC); On-site; USD 60,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Flexible PTO and holidays

Retirement programs

1% charitable giving program

Job summary

Veeva Systems is seeking a Computer Software Validation (CSV) professional with expertise in RTSM software to drive validation deliverables for a leading RTSM platform. This remote role supports global customers and collaborates with Development and Project Management teams to own the validation lifecycle.

You will create requirements, test scripts, and trace matrices, ensure test coverage, and maintain change controls to uphold product quality in a fast-paced environment.

Qualifications

• 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

Responsibilities

• 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

Skills

CSV experience

SDLC knowledge

GCP guidance

Attention to detail

English communication

Tools

Microsoft Word

Microsoft Excel

Job description

Veeva Systems is seeking a Computer Software Validation (CSV) professional with expertise in RTSM software to drive validation deliverables for a leading RTSM platform. This remote role supports global customers and collaborates with Development and Project Management teams to own the validation lifecycle.

You will create requirements, test scripts, and trace matrices, ensure test coverage, and maintain change controls to uphold product quality in a fast-paced environment.