Global Study Lead (FSP)
Core
Single accountable person leading global clinical study operations, strategy, and execution for a bio-pharma company.
Role type
Senior Clinical Study Lead (Global)
Builds
Global clinical studies for bio-pharma assets
Domain
Bio-pharmaceuticals / Clinical Development
Required skills
Global study management, cross-functional team leadership, vendor/CRO oversight, budget management, risk mitigation, regulatory compliance (ICH-GCP), stakeholder management, project management
Preferred skills
Oncology experience, Phase II-IV trial experience, FDA/EMA inspection readiness, China/Japan market exposure
Technologies
Clinical study management systems, risk management tools
Responsibilities
Own day-to-day global study management, develop operational plans and risk strategies, oversee country start-up and site activation, manage external vendors and CROs, monitor budgets and forecasts, ensure regulatory compliance and inspection readiness, lead cross-functional communication and governance meetings
Seniority
Senior, hands-on IC with strategic decision-making authority
