Global Study Lead

• Own the day-to-day management of the global clinical study
• Lead cross-functional study teams across clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, and other functions
• Align global study strategy with regional execution
• Drive study timelines, milestones, and deliverables
• Develop and maintain study timelines, operational plans, risk management plans, and enrollment strategies
• Oversee country start-up, site activation, recruitment, monitoring, and study closeout
• Ensure consistent global protocol execution
• Manage external vendors and CRO partners
• Track vendor performance metrics and service quality
• Resolve operational issues and escalations and ensure contractual and timeline compliance
• Monitor study budgets and forecasts and track spend against plan
• Identify resource gaps and operational risks
• Support financial governance and change management
• Identify study risks and lead mitigation and contingency planning
• Handle escalations involving recruitment delays, protocol deviations, data quality, supply shortages, and inspection readiness
• Ensure study conduct follows ICH-GCP, local regulations, SOPs, and protocol requirements
• Support inspection readiness and audit activities and oversee CAPAs when needed
• Serve as the central operational contact for the study
• Communicate updates to senior leadership, study teams, regional teams, sponsors, and partners
• Lead governance meetings and study reviews
• Monitor enrollment, data cleaning, query resolution, and database-lock readiness
• Review KPIs and operational metrics and ensure timely delivery of quality data
• Make operational decisions affecting study delivery while balancing quality, speed, cost, and patient safety
• Recommend process improvements and efficiencies

• Bachelor’s degree in life sciences or a related discipline
• At least 15+ years of relevant global study management experience
• In-depth clinical research experience, including study management, monitoring, and data management
• Previous in-depth oncology experience
• End-to-end global clinical study management experience across NA, EMEA, APAC, LATAM, China, and Japan; Africa experience is an asset
• Proven experience from study feasibility through Clinical Study Report (CSR)
• At least Phase II and Phase III experience; Phase I and Phase IV experience is an asset
• Proven cross-functional leadership experience
• Ability to contribute to clinical protocols, informed consent forms (ICFs), and other study plans
• Expertise in clinical study risk management and clinical systems
• Strong clinical budget management experience
• Strong vendor management experience, including CROs
• Experience with competent authority inspections, including FDA, EMA, MHRA, and PMDA; involvement in pivotal drug-registration studies is an asset
• Fluency in English sufficient to negotiate, discuss complex clinical topics, adapt messaging, and present clear status updates to upper management
• Excellent stakeholder management and oral and written communication skills
• Outstanding interpersonal skills
• Demonstrated leadership skills, including motivating and empowering others
• Strong understanding of clinical studies, drug development, sample management, associated processes, quality requirements, ICH/GCP guidelines, and SOPs
• Good project management skills covering scope, budget, timelines, resources, and associated tools

• Fully remote work arrangement
• Standard Monday–Friday work schedule