Global Study Lead
Core
Leading operational planning and execution of global clinical trials from study start-up through closeout, ensuring objectives are met on time, within budget, and in compliance with regulations.
Role type
Senior Manager, Clinical Operations (Global Study Lead)
Builds
End-to-end 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
Global clinical trial management, CRO oversight, budget management, risk mitigation, regulatory compliance (GCP), cross-functional team leadership, stakeholder management, project planning, financial variance analysis, mentorship
Preferred skills
Experience with Phase 3 registrational trials, experience in matrix organizations, MS Project proficiency
Technologies
MS Office Suite (Excel, Word, PowerPoint), MS Project
Responsibilities
Lead cross-functional trial teams to develop and execute study operational plans; Accountable for trial-level delivery including timelines, budget, quality, and milestones; Oversee CRO and vendor selection, onboarding, contracting, and performance monitoring; Proactively identify and mitigate operational risks; Ensure trial operationalization in compliance with global health authority regulations; Participate in Health Authority Inspections and internal QA audits; Mentor and support the development of Study Management colleagues; Interface with internal stakeholders including Finance, Regulatory, Data Management, and Medical Affairs; Provide variance analysis of budget to actual and notify finance of projected cost variances; Prepare and provide operational updates, risks, and recommendations to governance forums and leadership teams.
Seniority
Senior Manager, hands-on leadership
