Business Analyst Veeva Vault Clinical (CTMS/eTMF) - Remote - Full time

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About the role

This is a full-time, remote position focused on Veeva Vault Clinical (CTMS/eTMF) initiatives, including implementation, optimization, migrations, and strategic enhancements within a regulated clinical systems 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 Leadership.
• Serve as a Subject Matter Expert (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 Clinical Systems Leads, QA, Validation, and IT to ensure documentation supports validation, inspection readiness, and audit traceability.
• Lead or contribute to large-scale system migration from legacy CTMS (Gilda/Siebel) to Veeva Vault Clinical, including migration planning, cutover strategy, data validation, reconciliation, rollback planning, communications, change management, and archiving.
• Coordinate technical and business readiness across all stakeholder groups.
• Provide oversight and coordination for Veeva Vault Clinical releases across non-production and production environments.
• Partner with QA, Validation, and IT to ensure delivery aligns with GxP and validation expectations.
• Drive release impact assessments, cross-functional readiness reviews, and deployment sequencing.
• 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 Leadership.
• Lead routine internal Clinical Systems meetings to ensure alignment on technical and operational decisions, risks, and updates.
• 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

• Bachelor's degree preferably in Computer Science, Information Technology, Computer Engineering, or related IT discipline, or equivalent experience.
• 10-12+ years of experience as a Business Analyst delivering or leading regulated enterprise or clinical systems initiatives.
• Hands-on experience with Veeva Vault Clinical (CTMS and eTMF).
• Strong understanding of clinical trial operations and clinical systems workflows.
• 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.
• Proven ability to lead complex, cross-functional initiatives and drive clarity from ambiguity.
• Excellent executive communication, documentation, and stakeholder management skills.

Preferred Qualifications

• Experience with system integrations (e.g., CTMS ↔ eTMF/EDC/Data Lakes & repositories).