Join EY's Regulatory Compliance team as a Senior Business Analyst specializing in Veeva Vault Clinical. This role offers a unique opportunity to shape your career within a globally recognized firm, contributing to exceptional client experiences and a better working world. You will partner with business and IT stakeholders to design, implement, and optimize Veeva Vault Clinical applications in a regulated GxP environment.

As part of our dynamic team, you will help clients by understanding their business needs and delivering solutions aligned with EY's methodologies. You'll establish and strengthen relationships, drive projects to high-quality completion, and proactively manage risks. This position is ideal for someone looking to advance their consulting career and make a significant impact.

Key responsibilities include gathering and analyzing business requirements for Veeva Vault Clinical implementations, conducting workshops, and translating needs into detailed documentation such as Business Requirement Documents (BRD) and Functional Requirements Specifications. You will analyze current and future business processes, perform gap analysis, and support the configuration of Veeva Vault clinical modules. This role also involves coordinating user acceptance testing (UAT), supporting data migration, system integration, and release management activities. Developing training materials, SOPs, and user guides, and conducting end-user training are also crucial aspects of this position. Collaboration with cross-functional teams like clinical operations, regulatory affairs, and IT is essential for successful project delivery.

We are seeking a Senior Business Analyst with a Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field, coupled with 4–7 years of IT project experience in regulated environments. Proven hands-on experience with Veeva Vault clinical modules (eTMF, CTMS, Study Startup) and a solid understanding of their associated business processes are required. Experience in Agile/Scrum environments and a strong grasp of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 are essential. Candidates must possess excellent analytical, problem-solving, communication, and client interaction skills. Must-have skills include proficiency in requirements gathering tools (JIRA, Confluence), Veeva Vault configuration concepts, end-to-end clinical trial lifecycle knowledge, and validation methodologies like GAMP 5.