Are you ready to make a difference in the world of clinical research?
As a Global Study Manager (GSM) within Development Operations, you will be an integral part of the global study team, supporting the delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, and development of Clinical Study Report (CSR) to study archiving.
You will collaborate with internal and external partners to ensure the successful execution of delegated aspects of clinical studies across various therapeutic areas and phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.
).Your role will involve driving scope of work discussions, overseeing day-to-day activities delegated to vendors, providing status updates, and developing, reviewing, and approving related study documents.AccountabilitiesThe 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 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.Supports the Study Lead (GSAD, GSD) with developing and maintaining relevant study documents/plans (e.G., global study management plan and its relevant components).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.Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices.Participate in and/or lead departmental initiatives and/or SME function.Coordination and reporting of start-up and recruitment activities at the study level, across all countries.Monitoring and site oversight globally on assigned study(ies), representing the monitoring function on the CTT.Aggregation and communication of deliverables for assigned study(ies), globally, to the CTT and country teams respectively.Resourcing (with assistance of country teams) and study-related training of CRAs for assigned study(ies).Developing and/or reviewing applicable study documents including, but not limited to, training materials, clinical monitoring and oversight plans.Coordinating country teams activities related to key study events, such as protocol amendments, interim database locks, and Investigator Meetings.#J-18808-Ljbffr