Global Study Lead – FSP EMEA

• Lead the operational strategy and end-to-end delivery of one or more global clinical studies
• Own study timelines, budget, quality, risks and key operational deliverables
• Provide strategic leadership to global, cross-functional study teams and drive timely decision-making
• Represent Clinical Operations within the Study Leadership Team and act as the senior escalation point for operational issues
• Translate clinical development and asset strategy into study-level operational plans
• Lead proactive study risk identification, mitigation and issue resolution
• Ensure robust feasibility, study planning and operational execution
• Provide strategic operational input into protocols, informed consent forms and other key study documents
• Oversee CROs and external vendors, including vendor selection, performance management and escalation
• Ensure compliance with ICH-GCP, applicable regulations, SOPs and inspection-readiness requirements
• Lead study financial planning, forecasting and budget management
• Communicate study progress, risks, decisions and recommendations to senior stakeholders and governance forums
• Champion decentralised trial approaches, technology, automation and AI-enabled ways of working
• Contribute to Clinical Operations continuous improvement initiatives

• Bachelor's degree in Life Sciences or a related discipline
• Extensive experience in global clinical study delivery, ideally across multiple phases, indications and geographic regions
• Proven experience holding end-to-end accountability for complex global clinical trials
• Strong experience leading global cross-functional teams within a matrix environment
• Demonstrated ownership of study timelines, budgets, risks, quality and operational strategy
• Significant experience overseeing CROs and third-party vendors, including performance management and issue resolution
• In-depth knowledge of ICH-GCP, global regulatory requirements and clinical development processes
• Strong project and financial management capabilities
• Ability to influence senior stakeholders and drive decisions in complex, fast-paced environments
• Excellent leadership, communication, negotiation and conflict-management skills
• Experience proactively identifying and resolving risks that could impact clinical programmes
• Experience in Phase II and/or Phase III global clinical trials, adaptive or innovative trial designs, decentralised clinical trials, platform/umbrella/basket studies, technology-enabled delivery, automation or AI/ML, and working with investigators, external experts and regulatory authorities is highly desirable

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