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.Prepare, contribute, and distribute presentation material for meetings, newsletters, and websites.Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager. Essential Skills/Experience: Education in medical or biological sciences or discipline associated with clinical research preferredProven organizational and analytical skillsPrevious administrative training/experienceComputer proficiency in day-to-day tasksDevelop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelinesExcellent verbal and written communication in EnglishDemonstrate ability to work independently, as well as in a team environmentAbility to prepare presentation materials Desirable Skills/Experience: Bachelor level education (or higher)Proven study admin/assistant or relevant experience on a study levelExperience in clinical study lifecycle
Ready to make a difference? Apply now!
Date Posted 02-dic-2024
Closing Date 08-dic-2024
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
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