Role location - homebased
The Senior Study Leader is responsible for the execution and delivery of the Global Clinical Operations (GCO), clinical studies in accordance with the Operational Execution Plan (OEP) and clinical study protocol.
You will lead the cross-functional Clinical Trial Team (CTT) and guide the planning and management of assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GCO objectives.
Your responsibilities:
Your responsibilities include, but are not limited to:
• Lead the CTT delivery of multiple medium to complex global studies and promote learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and an agile team of teams model
• Guides planning and decisions at the study level and delivers assigned clinical study / studies per the Operational Execution Plan (OEP) and clinical study protocol
• In collaboration with regulatory writing and clinical development, promote operational excellence in the development of global clinical study protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documents
• Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximising collaboration and minimising dependencies to achieve long term business impact
• Responsible for developing clinical study timelines and overseeing assigned study budgets
• Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the Study & Site Operations (SSO) Clinical Project Manager Country representatives
• Proactive risk management and inspection readiness
• Promotes operational excellence and contributes to the development of Clinical Study Reports, reporting of clinical trial results, and internal/external publications, when appropriate