| Primary (must-haves): | 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 Subject Matter Expertise / Technical Leadership
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
Migration and Transformation Leadership
Lead or contribute to large-scale system migration, of 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
Validation, Compliance, Release and Environment Management
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
Executive Communication and Clinical Systems Leadership Enablement
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 |
| Detailed Job Description: | Required
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
Preferred
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 |
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