RC - REGULATORY COMPLIANCE - Clinical - CA - Veeva - Manager

EY

8–12 yrs Bengaluru Full Time Hybrid (office + remote)
EY logo
Posted : today
Actively hiring

Job description

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.

Responsibilities

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.

Qualifications

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.

Essential Skills

Veeva Vault Clinical SuiteeTMFCTMSStudy StartupGxP ComplianceCSV/CSA Methodologies21 CFR Part 11Project ManagementClinical OperationsLife Sciences ConsultingConfigurationWorkflow DesignMetadata ManagementICH-GCPALCOA+GDPRInspection Readiness

Good to Have

Business DevelopmentProposal SupportSolutioningGamp5 MethodologySDLCIQ/OQ/PQRisk-Based ValidationChange ControlTMF QualityProcess OptimizationAIAutomation

Highlights

  • Actively hiring

More Details

RoleRC - REGULATORY COMPLIANCE - Clinical - CA - Veeva - Manager
IndustryManagement Consulting, Pharmaceuticals, Biotechnology, Healthcare
DepartmentGeneral Management, Business Analysis
Employment TypeFull Time, Hybrid (office + remote)

About the Company

EY Global Delivery Services ( EY GDS) logo

EY Global Delivery Services ( EY GDS)

Management Consulting

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