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Veeva Vault Clinical Business Analyst/PM/SME-(CTMS/eTMF)

Tanisha Systems

Santa Clara, CA

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JOB DETAILS
SALARY
$120,000–$140,000 Per Year
JOB TYPE
Full-time, Employee
SKILLS
Acceptance Testing, Agile Programming Methodologies, Application Programming Interface (API), Biology, Biotech and Pharmaceutical, Business Analysis, Business Solutions, Change Management, Clinical Information Systems, Clinical Trial, Communication Skills, Communication Systems, Cross-Functional, Data Quality, DevOps, Documentation, Electronic Data Capture (EDC), Environmental Management, Establish Priorities, GxP, Information Technology & Information Systems, Large-Scale Systems, Leadership, Management Strategy, Metrics, Middleware, Migration Strategy, Production Systems, QA Partner Testing Software, Quality Assurance, Reconciliation, Release Management/Engineering, Release Notes, Requirements Management, Root Cause Analysis, Siebel, Standard Operating Procedures (SOP), Support Documentation, System Integration (SI), System Migration, Systems Analysis, Technical Leadership, Technical Writing, Test Plan/Schedule, Testing, Traceability, Translation Services, Validation Documentation, Validation Plan, Vendor/Supplier Management
LOCATION
Santa Clara, CA
POSTED
11 days ago
Veeva Vault Clinical Business Analyst/PM/SME-(CTMS/eTMF)
Full-Time / Contract (W2 / *)
Foster City, CA 94404 - Onsite role- Prefer local candidates
Salary – Market (DOE
Client - Life Science/Pharma

Skills & Experience
  • Business Analyst with 10-12+ years of experience 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
  • Bachelor’s degree in Life Sciences, Information Systems, or related field
Business Analysis Leadership/Execution & Veeva Vault Clinical Expertise
  • 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 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/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

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

Preferred / Nice-to-haves
  • Experience with system integrations (e.g., CTMS ↔ eTMF/EDC/Data Lakes & repositories)
  • Experience working with Siebel (CTMS), working with Veeva Managed Services or vendor escalations
  • Familiarity with Agile or DevOps methodologies; Knowledge of clinical metrics and reporting tools
  • Siebel CTMS experience, particularly in migration or decommissioning efforts
  • Experience with system integrations, APIs, middleware, and data platforms
  • Experience with Veeva Managed Services or external vendors
  • Exposure to operational metrics, reporting, or analytics in a clinical systems setting

About the Company

T

Tanisha Systems

INDUSTRY
Computer Software