Global Study Lead - FSP EMEA
Core
Provide strategic and operational leadership for complex global clinical studies from initiation to close-out, ensuring delivery to timelines, quality, and regulatory standards.
Role type
Senior Global Study Lead (Clinical Operations)
Builds
Global clinical studies across multiple phases and indications
Domain
Pharmaceutical/Biotechnology / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
end-to-end clinical study delivery, cross-functional team leadership, CRO/vendor management, ICH-GCP compliance, study financial planning, risk mitigation, protocol development input
Preferred skills
Phase II/III trial experience, adaptive trial designs, decentralized clinical trials (DCTs), platform/umbrella/basket studies, AI/ML-enabled trial delivery, broad therapeutic-area expertise
Technologies
AI-enabled ways of working, automation tools
Responsibilities
Lead operational strategy and end-to-end delivery of global clinical studies; Own study timelines, budget, quality, risks and key operational deliverables; Provide strategic leadership to global, cross-functional study teams; Represent Clinical Operations within the Study Leadership Team; Translate clinical development strategy into study-level operational plans; Oversee CROs and external vendors; Ensure compliance with ICH-GCP and regulations; Lead study financial planning and budget management; Champion innovative approaches including decentralized trials and automation
Seniority
Senior, hands-on IC
