Location: Barcelona (On-site).
We require 3 days working from the office and 2 days working from home.Type of Contract: 1 year Fixed term contract.The Global Study Associate (GSA) is a vital member of the extended global study team, supporting the delivery of clinical studies within Late Development Oncology (LDO) to time, cost, and quality standards.
From Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, and development of Clinical Study Report (CSR) to study archiving, the GSA plays a crucial role.
You will support the Global Study Director (GSD), Global Study Associate Director (GSAD), and Global Study Managers (GSMs) in various aspects of clinical study execution, adhering to the Study Team Operating Model (STOM), AZ Project Management Framework, current clinical trial regulations (e.G., ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies, and best practices.Accountabilities:Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) by completing delegated study work.Initiate and lead the set-up of the electronic Trial Master File (eTMF).
Maintain and close the eTMF to ensure compliance with International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.Interact/collaborate with Site Management & Monitoring, other internal staff, and external vendors in the collection of regulatory and other essential documents.Contribute to electronic applications/submissions in ANGEL by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities.Proactively plan and collate the administrative appendices for the CSR.Initiate and maintain production of study documents, ensuring template and version compliance per study-specific requirements.Set-up, populate, and accurately maintain information in AstraZeneca tracking and communication tools (e.G., IMPACT, SharePoint, BOX if used, MS Teams, and study team shared mailbox) and support team members in the usage of these tools.Support the set-up, maintenance, and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfill AstraZeneca compliance and meet regulatory authority needs.Support the GSD/GSAD with tracking, reconciliation, and follow-up of the study budget/payments in relevant systems (e.G., iBUY, FIND).Contribute to application, coordination, supply, and tracking of study materials and equipment.
Contribute to the collection of study supplies, if required, at the study close-out.Lead the practical arrangements coordination and contribute to the preparation of internal and external meetings e.G., study team meetings, committee meetings, monitor meetings, Investigator meetings, and virtual meetings.
Liaise with internal and external participants and/or vendors.#J-18808-Ljbffr