Global Study Lead
Core
Leading operational planning and execution of global clinical trials from start-up through closeout, ensuring objectives are met on time, within budget, and in compliance with regulations.
Role type
Senior Manager, Clinical Operations
Builds
Global clinical trials (Phase 1-4)
Domain
Biopharmaceuticals / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
End-to-end global trial execution, CRO/vendor management, budget management, risk mitigation, regulatory compliance (GCP), cross-functional team leadership, inspection readiness, financial variance analysis
Preferred skills
Phase 3 registrational trial experience, mentoring study management colleagues
Technologies
GCP, Health Authority regulations
Responsibilities
Lead cross-functional teams to develop and execute study operational plans; Accountable for trial-level delivery including timelines, budget, and quality; Oversee CRO and vendor selection, onboarding, and performance monitoring; Proactively identify and mitigate operational risks; Ensure compliance with global health authority regulations and internal procedures; Participate in Health Authority Inspections and internal QA audits; Mentor and support onboarding of Study Management colleagues; Interface with internal stakeholders (Finance, Regulatory, Data Management, etc.)
Seniority
Senior Manager, hands-on IC with mentorship responsibilities
