Associate Director, Clinical Capabilities Innovation
Core
Design, launch, and improve AI-enabled clinical operations capabilities, specifically within the eTMF ecosystem, to enhance efficiency, quality, and inspection readiness for clinical trials.
Role type
Senior IC Clinical Operations Innovation Lead (AI & Systems)
Builds
AI-enabled clinical operating models, agentic workflows for TMF intake/classification, and compliant system configurations within Veeva Vault.
Domain
Biopharmaceutical R&D / Clinical Operations / AI & Automation
Deliverable
production ML models | product features
Required skills
Clinical operations strategy, eTMF operations, Veeva Vault Clinical applications, system integrations, AI-enabled process design, GCP compliance, regulated document management, stakeholder partnership
Preferred skills
Veeva Vault Administrator certification, experience with automation/workflow design, experience translating business needs into system requirements
Technologies
Veeva Vault, AI/ML frameworks, APIs, workflow automation tools
Responsibilities
Lead design and implementation of AI-enabled clinical operations capabilities; translate clinical needs into AI process designs and decision logic; support delivery and lifecycle management of capabilities within Veeva Vault; monitor process performance and governance of AI-enabled clinical processes; build cross-functional partnerships with Clinical Ops, IT, and vendors.
Seniority
Senior, hands-on IC with strategic design focus