Duration: 4 months to start
Job Description:
Overview:
We are seeking an experienced Project Manager with deep domain expertise in Veeva Vault to support a rapidly growing biotechnology organization preparing for Phase 3 clinical trials. This individual will play a critical role in representing the client’s interests during multiple Veeva Vault implementations and ensuring business needs are fully realized.
This is not a traditional PM role—we are looking for a strategic, consultative leader and subject matter expert (SME) who can operate at both a business and technical level, guiding execution while influencing solution design and delivery.
This role will support implementation across three Veeva Vault modules:
- QMS (Events module)
- TMF (Trial Master File)
- CTMS (Clinical Trial Management System)
Veeva will provide an implementation team and PM. This role will serve as the client-side PM, ensuring alignment to business needs, technical environment, and enterprise standards.
Key Responsibilities:
Strategic Project Leadership:
- Serve as the client-side Project Manager and SME across all Veeva Vault implementations
- Provide strategic guidance on system design, implementation approach, and business alignment
- Ensure the solution meets clinical, regulatory, and operational requirements, not just vendor specifications
End-to-End IT Project Management:
- Lead core project management activities across implementation lifecycle, including:
- Project planning, scope definition, and schedule management
- Resource coordination and dependency tracking
- RAID management (risks, assumptions, issues, dependencies)
- Ensure adherence to SDLC and GxP-compliant implementation practices
- Establish and maintain project governance, reporting cadence, and escalation paths
Technical Oversight & Solution Alignment:
- Develop a strong understanding of the Veeva Vault architecture and module capabilities
- Oversee and provide input on:
- System configuration and functional design
- Technical integrations (e.g., CTMS integrations with EDC, eTMF, ERP, or other enterprise systems)
- Data migration strategy, including legacy data mapping, cleansing, validation, and reconciliation
- Ensure alignment with the organization’s enterprise architecture, data standards, and IT landscape
- Act as a bridge between business stakeholders and technical teams
Vendor & Partner Management:
- Partner closely with:
- Veeva implementation team and PM
- Third-party validation/testing partner
- Internal IT business partner and technical teams
- Drive vendor accountability and ensure deliverables meet agreed scope, quality, and timelines
- Coordinate across multiple vendors to ensure integrated delivery across systems and workstreams
Implementation Planning & Execution:
- Lead detailed implementation planning, including:
- Work breakdown structures and timelines
- Integration and data migration milestones
- Testing and validation phases
- Ensure alignment across functional, technical, and validation teams
- Support UAT readiness, defect management, and release planning
Change Management & Process Transformation:
- Guide business process design and optimization aligned to Vault capabilities
- Support organizational change management, including user readiness and adoption strategies
- Ensure impacts to people, process, and technology are fully considered and managed
Risk, Issue & Governance Management:
- Proactively identify, track, and mitigate project risks and issues
- Maintain transparency through robust status reporting and governance forums
- Adapt to and operate within various vendor PPM tools and methodologies
Executive Communication & Reporting:
- Deliver clear, executive-level status updates highlighting progress, risks, and decisions needed
- Facilitate alignment across senior stakeholders, business leaders, and IT partners
- Translate technical concepts into business-relevant insights
Required Qualifications:
- Extensive experience as a Project Manager leading IT system implementations in life sciences/biotech
- Strong hands-on experience with Veeva Vault, including:
- CTMS
- TMF
- QMS
- Proven experience delivering end-to-end system implementations, including:
- Data migration
- Systems integration
- Validation in regulated (GxP) environments
- Strong understanding of clinical operations, regulatory processes, and quality systems
Preferred Skills & Experience:
- Experience working in small to mid-sized biotech or emerging pharma environments
- Demonstrated experience managing complex vendor-led implementations
- Strong understanding of:
- Enterprise system integrations and data flows
- Clinical systems landscape (EDC, eTMF, CTMS, etc.)
- Experience with PPM tools and adapting to vendor methodologies
- Background supporting validation and testing efforts in regulated systems
Core Competencies:
- Strategic, consultative thinker with deep domain expertise
- Strong blend of business acumen and technical understanding
- Excellent written and verbal communication skills
- Ability to influence without authority and drive alignment across stakeholders
- Highly adaptable; thrives in fast-paced, evolving environments
- Collaborative, hands-on, and solutions-oriented mindset
