Regulatory Compliance Manager - Clinical, Veeva

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EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Manager – Veeva Clinical – Configuration Analyst

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Manager actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The Opportunity

We are looking for a seasoned and strategic Veeva Vault Clinical Manager to lead high-impact digital quality initiatives within the pharmaceutical domain. This opportunity is ideal for professionals who blend deep platform expertise with leadership and consulting acumen, and who thrive in regulated, client-facing environments. If you're passionate about driving transformation through technology and mentoring high-performing teams, this role is for you.

Role Overview

As a Veeva Clinical Manager, you will be responsible for leading implementation and management of Veeva Vault Clinical Suite to support global clinical trials. You act as the bridge between business stakeholders, clinical operations teams, and technical teams to ensure the platform is configured to meet business and regulatory requirements. Beyond implementation you will provide strategic guidance to clients drives process improvements, manages project delivery and ensure clinical operations are streamlined through Veeva’s capabilities.

Your key responsibilities

• Lead end-end-end implementation and deployment of the Veeva Vault Clinical Suite (eTMF, CTMS, Study Startup).
• Collaborate with business stakeholders to gather, analyze, and translate clinical business requirement into scalable Veeva solutions.
• Design and configure Veeva Vault applications, including workflows, lifecycles, security, roles, permissions, and business rules.
• Provide strategic consulting on clinical operations processes and recommend best practices aligned with industry standards.
• Manage project scope, timelines, budgets, risks, and deliverables to ensure successful project execution.
• Lead cross functional teams comprising business analysts, configuration specialists, developers, testers and validation teams.
• Oversee system integrations with EDC, e-consent, RIM, Safety, ERP, and other enterprise applications.
• Plan and manage data migration, ensuring data integrity and compliance throughout the migration lifecycle.
• Ensure CSV activities are completed in accordance with GxP, 21 CFR part 11, EU Annex 11, and ICH-GCP requirements.
• Drive User Acceptance Testing (UAT), defect management, release management, and production deployment activities.
• Mentor and coach team members, promote knowledge sharing, and support capability development.
• Drive continuous improvement by leveraging new Veeva Vault features, AI enabled capabilities, automation, and industry best practices.

Qualifications:

• Bachelor’s degree in computer science, Information Technology, or a related technical discipline.
• Proven proficiency in configuring the Veeva Vault platform, including objects, fields, roles, workflows, lifecycles, and reporting tools.
• Familiarity with Veeva APIs, Vault Loader, and other integration tools for data migration and system interoperability.
• Experience working in Agile/Scrum environments, contributing to iterative development and continuous improvement.
• Solid understanding of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 requirements in validated environments.
• Strong analytical and problem-solving abilities, with excellent communication, client interaction, and documentation skills.

Must-Have Skills & Attribute

• 8-12 years of experience in clinical operations, clinical systems, or life sciences consulting, with 3-5 years of hands-on experience implementing and configuring the Veeva Vault suite.
• Strong understanding of end-to-end clinical trial processes, including study startup, site management, Monitoring.
• Proven experience in Veeva Vault configuration, including lifecycle workflows, Metadata, SDK based enhancements.
• Extensive knowledge of global clinical regulations and standards including ICH-GCP, FDA 21 Part 11, EU annex 11 , GxP, ALCOA+ , GDPR, and inspection readiness requirements.

Good-to-Have Skills & Attributes

• Exposure to business development activities, including client engagement, proposal support, and solutioning.
• Solid understanding of GxP regulations, including FDA 21 CFR Part 11 and EU Annex 11.
• Ability to contribute to thought leadership, offering innovative insights and best practices in Vault implementation.
• Strong command of Gamp5 methodology, software development lifecycle (SDLC), computer system validation (CSV), IQ, PQ, OQ, risk-based validation and change control with regulatory environment.
• Experience designing implementation clinical workflows, lifecycle management, TMF quality, review, milestone tracking, issue management.
• Experience in process optimization and operational efficiency initiatives, aligning technology with business outcomes.
• Strategic mindset with the ability to align Vault capabilities with digital transformation goals.
• High attention to detail, with strong analytical and critical thinking skills.
• Adaptability to evolving regulatory landscapes and business priorities.
• Strong problem-solving and decision-making abilities in complex, fast-paced environments.

What working at EY offers

At EY, we’re dedicated to helping our clients, from startups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way that’s right for you

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