Job Description
Role & responsibilities :
The role provides senior business analysis and leadership for complex, crossfunctional initiatives involving Veeva Vault Clinical (CTMS/eTMF), including implementations, optimizations, migrations, and strategic enhancements. It translates ambiguity into clear scope, success criteria, delivery plans, timelines, risks, and executive decision points. Acting as a senior Veeva Vault Clinical SME, the role advises on system configuration, functional capabilities, integrations, and downstream impacts while partnering with development and support teams on complex issue resolution. It contributes to enhancement prioritization, solution design, and validation strategy, and ensures endtoend workflow alignment across clinical, integration, and data teams. The role leads or supports largescale migrations from legacy CTMS systems to Veeva Vault Clinical, covering cutover, data validation, reconciliation, rollback, change management, and archiving. It provides governance over validation, compliance, and release management across nonproduction and production environments in alignment with GxP expectations. The role ensures documentation quality, inspection readiness, and audit traceability through close collaboration with QA, Validation, IT, and Clinical Systems leads. It serves as a trusted advisor to the Clinical Systems Leadership Team, delivering concise executive communications on progress, risks, and tradeoffs. Overall, the role drives alignment and outcomes across senior stakeholders with minimal oversight while ensuring compliant, predictable, and businessaligned delivery.
Primary Skills (Must have skills):
- 5+ years of experience with Veeva Vault Clinical (CTMS) - Vault Clinical certification highly preferred.
- Strong analytical, problem-solving, and communication (written / presenting) skills
- 5+ years of Experience in gathering, documenting, and managing business and functional requirements
- 5+ years of Experience in creating process flows, user stories, use cases, and related documentation
- 5+ years of Experience in supporting UAT, defect management, and validation activities in regulated environments
- Understanding of clinical trial operations and supporting business processes
- Ability to work effectively with business users, technical teams, and validation partners
Preferred candidate profile
Business Analysis Leadership and Execution
- Lead complex, cross-functional initiatives related to Veeva Vault Clinical (CTMS/eTMF), including: implementation, optimization efforts, migrations, and strategic enhancements
- Convert ambiguity into clear problem statements, scope, success criteria, execution plans, timelines, risks, and decision points
- Proactively manage dependencies, trade-offs, and risks; elevate decisions with clear recommendations to Clinical Systems LT
Veeva Vault Clinical Functional Expertise
- Demonstrate strong functional working knowledge of Veeva Vault Clinical (CTMS) and considered a domain expert.
- Understand Vault Clinical workflows, object relationships, lifecycle states, security models, and business processes
- Support / Lead system configuration discussions and evaluate impacts of proposed changes
- Support / Lead investigation and analysis of production issues and enhancement requests
- Collaborate with business, support, validation, and technical teams to deliver solutions
- Participate in requirements reviews, solution reviews, and user acceptance activities
Veeva Vault Clinical Business Analysis
- Support business analysis activities for Veeva Vault Clinical (CTMS/eTMF) enhancements, projects, and ongoing operations
- Support impact assessments for new functionality, configuration changes, and releases
- Analyze and help develop business processes and identify opportunities for system improvements and optimization
- Partner with cross-functional stakeholders to gather, document, and refine business requirements and user stories
- Assist in defining functional requirements, acceptance criteria, and business scenarios
- Translate business needs into clear and actionable requirements for technical teams
Documentation and Validation Support
- Create and maintain business requirements, process flows, user stories, traceability documentation, and training materials
- Review functional specifications, release documentation, test scripts, and validation deliverables for completeness and accuracy
- Support UAT planning, execution, defect tracking, and resolution activities
- Ensure documentation aligns with business requirements and regulated system expectations
- Assist with audit and inspection readiness activities through accurate documentation and traceability
Clinical Systems Operations Support
- Support release impact assessments and business readiness activities
- Assist in coordination of testing and deployment activities across stakeholder groups
- Support business process harmonization and standardization efforts
- Contribute to continuous improvement initiatives within the Vault Clinical landscape