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

Job Description

Pinnacle Method Consulting is seeking a Business Analyst Veeva Vault Clinical (CTMS/eTMF) for a Full Time Project in Remote. The position requires a Bachelor's degree in Computer Science, Information Technology, Computer Engineering, or a related IT discipline with at least 12 years of experience, preferably 10-12 years. Key responsibilities include:

• 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.
• Technical fluency to partner effectively with internal and external teams in Business, IT, Data, Infrastructure, and QAD.
• 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.

Skills & Experience

Essential skills and experience include:

• Business Analyst with 10-12+ years of experience.
• Strong understanding of clinical trial operations and clinical systems workflows.
• Technical fluency to partner effectively with internal and external teams in Business, IT, Data, Infrastructure, and QAD.
• 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.

Business Analysis Leadership/Execution & Veeva Vault Clinical Expertise

Key responsibilities include:

• 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 LTS.
• Partner with development and support teams on complex or systemic issues, contributing to root-cause analysis and long-term solutions.
• 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.
• Partner with CS Leads, QA, Val, and IT to ensure documentation supports validation, inspection readiness, and audit traceability.
• Participate in enhancement definition, prioritization, solution design, and validation strategy.
• Act as a translator between technical and business audiences, validating that documentation clearly reflects scope, assumptions, risks, and downstream impacts.
• Provide oversight and contribution to validation approaches, UAT strategy, and release documentation.

Migration and Transformation Leadership

Key responsibilities include:

• Lead/contribute to large-scale system migration, of Client 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

Key responsibilities include:

• 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

Key responsibilities include:

• Operate as a trusted advisor and analyst for Clinical Systems LT.
• Lead routine internal Clinical Systems Meetings 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.