SSU Lead (Veeva Vault ClinOps)
Remote UK/Europe / contract / Negotiable
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.
London, UK
3rd Floor, News Building, 3 London Bridge Street, London, SE1 9SG
Tel: +44 (0) 203 435 6960
info@vineresources.com
Berlin, Germany
Gontardstrabe 11 Berlin, 10178
Tel: +49 (0) 30 2178 3212
info@vineresources.com
Brisbane, Australia
Level 4, 80 Ann Street, Brisbane, Queensland, 4000
Tel: +61 (0) 7 2115 0876
info@vineresources.com
New York, USA
1250 Broadway, 36th Floor New York, NY 10001
Tel: +1 (332) 209-2109
info@vineresources.com
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