Senior Veeva Business Analyst

Falcon Smart IT is seeking a Senior Veeva Business Analyst to lead complex, cross-functional initiatives related to Veeva Vault Clinical. The role involves providing technical leadership, managing system migrations, and ensuring compliance and validation in a regulated environment.

Responsibilities:

• 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
• Serve as a senior SME for Veeva Vault Clinical (CTMS/eTMF), advising on configuration implications, functional capabilities, and downstream system impacts
• Partner with development and support teams on complex or systemic issues, contributing to root-cause analysis and long-term solutions
• Participate in enhancement definition, prioritization, solution design, and validation strategy
• Collaborate closely with integration and data teams on end-to-end clinical system workflows
• Review key technical and functional documentation, including business and system requirements, design specifications, release notes, validation plans, and SOPs
• Ensure documentation is complete, accurate, and aligned with intended business outcomes, system behavior, and regulatory expectations
• Act as a translator between technical and business audiences, validating that documentation clearly reflects scope, assumptions, risks, and downstream impacts
• Partner with CS Leads, QA, Val, and IT to ensure documentation supports validation, inspection readiness, and audit traceability
• Lead or contribute to large-scale system migration, of Gilead's legacy CTMS Gilda (Siebel) to Veeva Vault Clinical and related transformation efforts
• Drive/participate in migration planning, including cutover strategy, data validation approach, reconciliation methods, rollback planning, communications, change management, and archiving strategy
• Help to coordinate technical and business readiness across all stakeholder groups
• Provide oversight and coordination for Veeva Vault Clinical releases across non-production and production environments
• As needed, partner with QA, Val, and IT to ensure delivery aligns with GxP and validation expectations
• Drive release impact assessments, cross-functional readiness reviews, and deployment sequencing in partnership with IT, QA, Val and development teams
• Ensure appropriate governance and usage of development, test, and UAT environments to support parallel workstreams and testing cycles
• Act as a single point of orchestration for release- and environment-related dependencies, risks, and conflicts
• Ensure releases are executed in a compliant, predictable, and business-aligned manner
• Provide oversight and contribution to validation approaches, UAT strategy, and release documentation
• Operate as a trusted advisor and analyst for Clinical Systems LT
• Lead routine internal Clinical Systems Meeting to ensure internal alignment on technical and operational decisions/risks/updates on the Vault Clinical program
• Deliver concise, executive-ready communication on progress, risks, trade-offs, and decisions required
• Influence with minimal oversight to gain alignment and drive outcomes across senior stakeholder groups

Requirements:

• 10 to 20 years' experience
• Pharma or life Science Domain -Must
• Bachelor's degree in Life Sciences, Information Systems, or related field
• 8–12+ years of experience delivering or leading regulated enterprise or clinical systems initiatives
• Deep hands-on experience with Veeva Vault Clinical (CTMS and eTMF)
• Strong understanding of clinical trial operations and clinical systems workflows
• Proven ability to lead complex, cross-functional initiatives and drive clarity from ambiguity
• Strong technical fluency to partner effectively with internal and external teams in Business, IT, Data, Infrastructure, and QA
• Demonstrated experience overseeing release and environment management in a GxP-regulated environment
• Excellent executive communication, documentation, and stakeholder management skills
• Siebel CTMS experience, particularly in migration or decommissioning efforts
• Experience with system integrations, APIs, middleware, and data platforms
• Experience working with Veeva Managed Services or external vendors
• Familiarity with Agile or DevOps delivery approaches
• Exposure to operational metrics, reporting, or analytics in a clinical systems setting
• Experience with system integrations (e.g., CTMS ↔ eTMF/EDC/Data Lakes & repositories)
• Experience working with Siebel (CTMS)
• Experience working with Veeva Managed Services or vendor escalations
• Familiarity with Agile or DevOps methodologies
• Knowledge of clinical metrics and reporting tools