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.