GlobalStudyManager

**This is what you will do:** The Global Study Manager (GSM), is a role within Development Operations and is a member of the global study team supporting delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. The GSM works with internal and external partners to deliver delegated aspects of the clinical study in accordance with the Study Lead . The GSM will drive the scope of work discussions and oversee delivery of day-to-day activities delegated to the vendors. The GSM will provide status updates and performance metrics and develop, review and approve related study documents. Studies may be across various therapeutic areas and all phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.). **You will be responsible for:** * The strategy, set up and oversight of key vendors in support of study deliverables according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the vendors is maintained and documented through the life cycle of the study. * Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives. * Contributes to the planning and conduct of internal and external meetings (e.g.Investigators’/Monitors’ meeting). * Supports the Study Lead with budget management, such as external service provider invoice reconciliation. As well as developing and maintaining relevant study documents/plans (e.g., global study management plan and its relevant components, etc.). * Perform Study Lead activities for less-complex studies (e.g., small studies, studies in conduct or close-out, OLE, etc.). * Delegate and oversee team member responsibilities. *