We are seeking an experienced SSU Lead with deep Veeva Vault expertise to join an enterprise Clinical Operations transformation project.

This role is responsible for driving Study Start up (SSU) processes, optimising Veeva Vault configurations, and bridging the gap between business needs and system architecture.

Key Responsibilities:

• Process Analysis & Testing: Analyse, test, and document Clinical Operations processes within the Vault ClinOps suite, focusing on Study Startup and Vault Connections.
• Requirement Gathering & Documentation: Formulate process recommendations, define user requirements (URS), and build user stories aligned with business processes.
• System Risk Assessment: Conduct GxP and Non-GxP risk assessments and ensure alignment with Computer Systems Validation (CSV) expectations.
• Stakeholder Collaboration: Lead alignment sessions with business stakeholders, functional teams, and external partners.
• Training & Go-Live Support: Deliver knowledge transfer sessions, review training documentation, and provide user consultation through post-rollout hypercare.

Experience

• 10 years of experience within Clinical Operations with a primary focus on Study Startup (SSU).
• In-depth functional experience configuring and implementing Veeva Vault ClinOps (Study Startup).
• Proven track record in Agile environments, business process modelling, and GxP risk analysis.