Veeva Systems

Analyst - Computer Software Validation (Remote)

Madison, Wisconsin, United States

Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, SaaS, Enterprise SoftwareIndustries

Requirements

Candidates should possess at least one year of experience in computer software validation specifically for clinical trial software, such as CTMS, CDMS, or eTMF. They should have a working knowledge of the software development lifecycle (SDLC) and familiarity with Good Clinical Practice (GCP) guidelines, including 21 CFR Part 11 and EU Annex 11.

Responsibilities

The Analyst - Computer Software Validation will participate in requirement gathering sessions with clients and the RTSM team, collaborate closely with Development and Project Management teams to ensure requirements are clearly defined and testable, develop and maintain CSV deliverables like requirements specifications, test scripts, and summary reports, manage validation testing cycles and resolve issues, maintain change control documentation, provide technical expertise in computer system validation and quality system requirements, and support customers with RTSM validation activities.

Skills

CSV
Clinical Trial Software
GCP
21 CFR Part 11
EU Annex 11
SDLC
Requirements Gathering
Test Script Development
Change Control
Validation Testing

Veeva Systems

Quality and regulatory software solutions provider

About Veeva Systems

Veeva Systems offers software solutions for quality, regulatory, and advertising claims management, focusing on consumer products and chemical companies. Their cloud-based platform provides visibility and traceability throughout the product journey, ensuring compliance with regulations and accelerating time-to-market. Unlike competitors, Veeva has specialized expertise in both the Life Sciences and Chemical sectors, allowing them to effectively address industry-specific challenges. The company's goal is to help clients efficiently bring safe and compliant products to market.

Key Metrics

Pleasanton, CaliforniaHeadquarters
2007Year Founded
$6.8MTotal Funding
IPOCompany Stage
Enterprise Software, Healthcare, Consumer GoodsIndustries
5,001-10,000Employees

Benefits

Parental leave
PTO
Free food
Health, dental, & vision insurance
Gym membership reimbursement

Risks

Manual processes in medtech content management risk compliance issues and market delays.
GenAI features in Vault CRM may face data privacy and security challenges.
Rapid product expansion could lead to integration challenges and customer dissatisfaction.

Differentiation

Veeva Systems specializes in cloud-based software for the life sciences industry.
The company offers a subscription-based model ensuring continuous updates and improvements.
Veeva's Vault CRM Suite connects sales, marketing, and medical for customer-centric engagement.

Upsides

Veeva Compass Patient platform supports patient journey analysis and market sizing.
GenAI features in Vault CRM enhance field productivity with contextual task automation.
Veeva's digital HACCP solution improves safety and efficiency in compliance processes.

Land your dream remote job 3x faster with AI