RC-REGULATORY COMPLIANCE-Clinical - BA -Veeva-Senior

Job description

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance Senior- Business Analyst (Veeva Clinical). At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. 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 senior 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 seeking a Senior Business Analyst – Veeva Vault Clinical with proven consulting experience to partner with business and IT stakeholders in designing, implementing, and optimizing Veeva Vault Clinical applications, including eTMF, CTMS, Study Startup with regulated GxP environment. You will lead discovery workshops, gather and analyse business requirements, define future-state clinical processes, and translate business needs into scalable Veeva solutions that enhance operational efficiency and regulatory compliance. Role Overview As a Business Analyst, you will work closely with clients and cross-functional teams to translate business needs into functional specifications, lead workshops, and ensure compliance with global regulatory standards. You will contribute to projects involving Veeva Vault Clinical enabling process harmonization, data migration activities ensuring compliance. Your key responsibilities Gather, analyze, and document business requirements for Veeva Vault implementations (Clinical Suite). Gather and analyze business requirements from clinical operations, study startup, and TMF Stakeholders. Conduct workshops and requirements elicitation sessions with business users. Translate business needs into Business Requirement Documents (BRD), Functional requirements specifications. Analyze current and future business processes and perform gap analysis. Support configuration of Veeva Vault clinical modules (CTS, eTMF, Study Startup, Site connect). Prepare process flow, functional specifications and configuration documentation. Coordinate user acceptance testing (UAT), develop test scenarios, and support defect resolution. Support Data migration, system integration, and release management activities. Manage change requests and assess their business impact. Develop training materials, SOPs, and user guides and conduct end user training. Collaborate with cross-functional teams including clinical operations, regulatory affairs, data management m quality assurance and IT to ensure successful implementation of Veeva clinical solutions. Qualifications: Bachelor’s degree in computer science, Information Technology, Life Sciences or a related field. 4–7 years of experience as a Business Analyst in IT projects within regulated environments. Hands-on experience with Veeva Vault clinical modules with demonstrated expertise in related business processes and workflows 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 & Attributes Proven experience in requirements gathering and documentation using tools like JIRA, Confluence, ALM, Lucid, Visio, Mural, etc. Hands-on Knowledge of Veeva Vault clinical Suite (CTMS, eTMF, Study Startup, site connect). Understanding of Vault configuration concepts (objects, lifecycles, workflow, security, page layouts). Knowledge of Veeva Clinical implementation and release management. Knowledge of end-to-end clinical trial lifecycle. Strong understanding of GAMP 5 methodology, System Development Life Cycle (SDLC), and validation planning Proficiency in testing and validation tools such as qTest and ALM, with strong dashboarding and reporting capabilities. Knowledge of data migration concepts, integration fundamentals, clinical system interfaces and basic SQL. Ability to collaborate with cross-functional teams (QA, IT, Manufacturing, Labs, Safety, Regulatory) Experience in client-facing roles, managing expectations and delivering solutions Experience in IT project management and validation planning Proven ability to mentor junior resources Experience in training and cross-skilling resources Strong teamwork and collaboration mindset Good-to-Have Skills & Attributes Experience with Veeva Clinical Suite implementation (CTMS, eTMF, Study Startup, Site connect). Knowledge of Veeva Vault platform administration and advanced configuration. Understanding of clinical data standards (CDISC, SDTM, ADaM). Experience with Power BI, Tableau or clinical analytical dashboard. Exposure to business development activities and client engagement strategies Exposure to regulatory compliance (FDA, EMA) and audit remediation. Familiarity with integrations between Vault and enterprise systems (SAP, LIMS, MES) Ability to create innovative insights and contribute to thought leadership Experience in process optimization and operational efficiency initiatives Ability to align technology with business transformation goals High attention to detail and analytical thinking Adaptability to changing regulatory and business environments Strong problem-solving and decision-making abilities What we look for A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries 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 EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.