Global Study Lead - FSP Team
Core
Leading operational strategy, planning, and end-to-end delivery of clinical studies from initiation to archiving, ensuring success in time, quality, and budget.
Role type
Senior IC Global Study Lead (Clinical Operations)
Builds
Clinical study deliverables for pharmaceutical programs
Domain
Pharmaceutical industry / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, clinical development expertise, global regulatory guidelines (ICH/GCP) knowledge, budget management, stakeholder management at senior levels, matrix team leadership, vendor management, innovative trial design (adaptive, DCT), project management
Preferred skills
Experience with decentralized clinical trials (DCT), platform/umbrella/basket trial designs, automation of manual processes, therapeutic area expertise
Technologies
AIML tools, DCT platforms
Responsibilities
Lead operational strategy and delivery of clinical studies; serve as escalation point for Clinical Operations; ensure compliance with ICH/GCP and company SOPs; manage study budget and feasibility; lead matrix teams and working groups; oversee vendor selection and performance; drive process improvement and innovative trial designs; provide strategic oversight on protocol development.
Seniority
Senior, hands-on IC with strategic leadership
