Clinical Research

• Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality
• Lead all aspects of assigned clinical studies
• Lead global cross-functional study teams, including oversight of external partners, and act as point of escalation
• Align study goals with clinical operations and corporate goals and objectives
• Lead external vendor management and collaborate with regional subject matter experts
• Provide regular study progress updates to senior management
• Lead planning and management from feasibility through closeout
• Manage study timelines, feasibility, trial allocation, site selection, startup, and site activation
• Ensure timely availability and quality of study documents for regulatory and ethics submissions
• Create, maintain, and implement study plans, systems, tools, training records, and Trial Master Files
• Implement risk-based quality management processes and support data cleaning timelines
• Plan and execute Clinical Study Reports with Medical Writing and study team members
• Monitor compliance with protocol, SOPs, ICH/GCP, study plans, and regulations
• Manage quality metrics, inspection readiness, audits, inspections, risks, and corrective/preventive actions
• Develop and share best practices and contribute to SOP and work-instruction improvements
• Select and manage study vendors and approve invoice payments
• Manage study budgets, forecasts, accruals, resources, and contingency plans
• Ensure studies are executed within approved timelines, quality, and cost parameters
• Provide performance feedback on team members as required

Explore Global Clinical Study Manager at BeOne Medicines. Review requirements and application details.

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