Our client seeks an Business Analyst Veeva CTMS / eTMF for a Full Time project in Remote. Below is the detailed requirement
Job Title: Business Analyst Veeva CTMS / eTMF
Work location : Remote
Duration: Full Time
Job Description:
- Bachelor's degree preferably in Computer Science, Information technology, Computer Engineering, or related IT discipline or equivalent experience with 12+ Minimum Experience
Skills & Experience
- Business Analyst with 10 years of experience delivering/leading regulated enterprise/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
- Act as a translator between technical and business audiences, validating that documentation clearly reflects scope, assumptions, risks, and downstream impacts
- 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
Migration and Transformation Leadership –– Lead/contribute to large-scale system migration legacy CTMS (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.
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