Global Study Manager

Detalles de la oferta

.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 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.Supports the Study Lead (GSAD, GSD) with 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.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


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

Project Manager

Se trata de una vacante estable de contratación directa con la empresa, con proyección de carrera interna, por lo que podrás olvidarte de la incertidumbre de...


Your Talent Side - Barcelona

Publicado 12 days ago

Project Manager Responsable De Producto

Desde Global Consulting , Consultoría de Selección de perfiles Technical, Middle, C-Suite, buscamos a un/a Project Manager responsable de producto   con al m...


Iman Global Consulting - Barcelona

Publicado 12 days ago

Project Manager - I&Td

I&TD PMO Manager Are you a dynamic project management professional seeking an opportunity to make a significant impact in the pharmaceutical industry? We are...


Panda International - Barcelona

Publicado 12 days ago

Gerente De Obra En Alemania

Desde IMAN Temporing, empresa especializada en RRHH, queremos acompañarte en tu trayectoria laboral. #Conectamoseltalentoconlasoportunidades Estamos buscando...


Iman Temporing Empresa De Trabajo Temporal Sl - Barcelona

Publicado 12 days ago

Built at: 2024-11-27T15:49:42.149Z