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Veeva Systems Applications Owner - Consultant

Brisbane, CA · Biotech/Pharmaceutical
Title: Veeva Systems Applications Owner - Consultant

Type of role: 12+ Month Contract - Hybrid (onsite Wednesdays and Thursdays)
Client Location: Brisbane, CA 94005

***Must have previously worked on Veeva Validation in the Pharmaceutical and/or Biotech domain.***

 
The Veeva Systems Applications Owner will support maintenance and enhancement of IT R&D systems.  The ideal candidate will be well versed in ITSM and IT Change Management, have technical experience in managing IT R&D Systems as well as experience in Business Analysis, Project Management, Release Management and Production Support of hosted and SaaS IT R&D systems.
 
Responsibilities:
  • Work with the IT R&D lead to establish and maintain IT Roadmaps by aligning with business teams on new demand, provide updates on existing projects. Ensure initiatives are delivered on time and within scope.
  • Lead System Maintenance and Enhancement (M&E), understand new M&E requests from the business.
  • Perform impact assessment on existing functionality and design and prioritize new system enhancement requests for sprint planning.
  • Review technical specifications and design and provide technical feedback to ensure solution is scalable and optimal.
  • Oversee end-to-end system implementation from a functional and technical standpoint and work with vendor to resolve issues.
  • Collaborate with BSO and project team on roll-out planning by understanding dependencies, approving the release plan, managing the IT Change Request, and driving the overall implementation process.
  • Ensure timely support and resolution of production issues by performing initial analysis and triaging issues and support tickets.
  • Coordinate and work with IT Compliance to ensure GxP compliance on all initiatives.
  • Work with vendors to perform requirements walkthrough, technical reviews, testing in Production and non-Production environments.  
Technical Requirements:
  • 4+ years of relevant experience working with Clinical and Regulatory IT R&D systems. Hands-on experience with the following systems is required: 
    • Veeva Vault RIM - Registrations, Submissions, Submissions Archive and Publishing
    • Veeva Clinical - eTMF, CTMS and Payments
  • Experience working with ServiceNow, Okta and working knowledge of MuleSoft middleware
  • Veeva certified Vault owner training and experience is highly recommended.
  • Ability to provide solutions at a technical level and review technical solutions recommended by vendors.
  • Experience in business processes for clinical and regulatory systems.
  • Proficient with relational databases and reporting tools (e.g., PowerBI,).
  • Experience with System Development Lifecycle (SDLC) in a regulated environment including integrations using APIs
  • Bachelor’s degree in Information Technology, Computer Systems, Information Systems or related field from a 4-year accredited institution.

 
Dawn West
AdeptSource
 

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