Duration: 4 months to start
Job Description:
Overview:
We are seeking an experienced IT Business Partner with deep Veeva Vault expertise to support a growing biotechnology organization preparing for Phase 3 clinical trials.
This role is a blend of Veeva SME, strategic business analyst, and executive-facing advisor, serving as the primary interface between IT and Clinical functions (Clinical Operations, Biostats, and Data Management).
The individual will play a critical role in translating real-world business needs into scalable Veeva Vault solutions, with a strong focus on the implementation of TMF, CTMS, QMS, while also supporting broader clinical initiatives such as RBQM and Portfolio Planning.
Key Responsibilities:
Business Partnership & Advisory:
- Serve as the IT Business Partner for Clinical, Biostats, and Data Management
- Build strong relationships with business stakeholders to understand workflows, pain points, and strategic goals
- Act as a trusted advisor to senior leaders, translating business needs into technology solutions
- Facilitate alignment between business priorities and IT strategy
Veeva Vault SME & Solution Scoping:
- Function as a subject matter expert across Veeva Vault (TMF, CTMS, QMS)
- Lead discovery and scoping for implementations (primarily TMF and CTMS), ensuring business processes are accurately captured
- Assess how Vault capabilities align to real-world clinical operations and identify gaps or optimization opportunities
- Define requirements that inform scope and solution design
Business Analysis & Process Design:
- Conduct high-level business analysis, including process mapping, requirements gathering, and gap analysis
- Translate complex clinical processes into clear functional and technical requirements
- Guide workflow design and process standardization aligned to Vault capabilities
- Ensure solutions support regulatory, operational, and data integrity requirements
Cross-Functional & Program Support:
- Partner with Project Managers, IT teams, and vendors to ensure business intent is maintained throughout delivery
- Support parallel scoping and strategy efforts for RBQM and Portfolio Planning initiatives
- Provide input on integration points, data flows, and upstream/downstream impacts
Executive Communication & Stakeholder Alignment:
- Present findings, recommendations, and roadmap options to executive stakeholders
- Translate technical concepts into business-relevant insights and decisions
- Drive alignment across Clinical, IT, and external partners
Change & Adoption Readiness:
- Identify impacts to people, process, and technology
- Support organizational readiness, adoption strategies, and business engagement
- Advocate for solutions that balance usability, compliance, and scalability
Required Qualifications:
- Proven experience as an IT Business Partner, Business Analyst, or similar role in life sciences/biotech
- Strong hands-on Veeva Vault expertise (TMF, CTMS, QMS)
- Deep understanding of clinical operations, trial management, and data management processes
- Experience with system implementation scoping, requirements definition, and process design
- Ability to operate effectively at both strategic and detailed levels
Preferred Skills & Experience:
- Experience with RBQM (Risk-Based Quality Management) and/or clinical portfolio planning
- Background supporting Veeva Vault implementations or transformations
- Knowledge of clinical systems ecosystem (EDC, eTMF, CTMS, etc.) and integrations
- Experience working in emerging biotech or fast-paced environments
- Familiarity with vendor-led implementations and contract scoping
Core Competencies:
- Strategic, consultative thinker with strong business and technical acumen
- Excellent stakeholder engagement and executive communication skills
- Ability to translate complex processes into actionable solutions
- Influential, collaborative, and highly adaptable
- Hands-on, curious, and solutions-oriented mindset
