RC - REGULATORY COMPLIANCE - Clinical - CA - Veeva - Manager
EY
EY
Join EY's Enterprise Risk Regulatory Compliance team as a Veeva Clinical Manager and drive impactful digital quality initiatives in the pharmaceutical sector. This role is perfect for professionals with deep Veeva platform expertise, strong leadership abilities, and experience in regulated, client-facing environments. If you are passionate about technological transformation and leading high-performing teams, this is your opportunity to build an exceptional career.
Lead end-to-end implementation and deployment of the Veeva Vault Clinical Suite (eTMF, CTMS, Study Startup). Gather and translate clinical business requirements into scalable Veeva solutions. Design and configure Veeva Vault applications, including workflows, lifecycles, security, roles, and permissions. Provide strategic consulting on clinical operations processes and manage project delivery, scope, timelines, and budgets. Oversee system integrations, data migration, and ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and ICH-GCP. Drive UAT, defect management, and production deployment, while mentoring team members and promoting continuous improvement.
A Bachelor's degree in Computer Science, Information Technology, or a related field is required. You need proven proficiency in configuring the Veeva Vault platform, including objects, fields, workflows, and reporting tools. Familiarity with Veeva APIs and integration tools is essential, as is experience in Agile/Scrum environments. A solid understanding of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 requirements in validated environments is crucial. Excellent analytical, problem-solving, communication, and client interaction skills are necessary.
EY Global Delivery Services ( EY GDS)
Management Consulting