19 oct
|
AstraZeneca
|
Barcelona
19 oct
AstraZeneca
Barcelona
The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clincial Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. Desplácese hacia abajo para encontrar los detalles completos de la oferta de trabajo, incluyendo la experiencia requerida y las funciones y tareas asociadas. The GSM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Global Study Director (GSD) or Integral Study Associate Director (GSAD) in delegated aspects of clinical study execution in accordance with the Delivery Model, AZ Project Management Framework, current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviours.
Typical Accountabilities * In partnership with AZ team, other AZ clinical experts and external service providers, the GSM provides oversight to ensure study delivery. * Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc). * Maintains and facilitates interactions with internal functions 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). * Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate. * Proactively contributes to risk
📌 Global Study Manager (Barcelona)
🏢 AstraZeneca
📍 Barcelona