Job Summary

EY GDS Consulting Enterprise Risk (ER) Regulatory Compliance Senior- Business Analyst (Veeva Clinical).

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, youll 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
- Bachelors degree in computer science, Information Technology, Life Sciences or a related field.
- 47 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.
- Solid 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)

📌 RC-REGULATORY COMPLIANCE-Clinical - BA -Veeva-Senior (Hyderabad)
🏢 EY
📍 Hyderabad