The GSA is a member of extended global study team supporting delivery of clinical studies within Late Development Oncology (LDO) 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.
The GSA supports Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) in delegated aspects of clinical study execution in accordance with 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 (e.g. AZ guidelines) and in line with AZ values and behaviours.
Responsibilities:
- Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global StudyManagers (GSMs) by completing delegated study work.
- Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close theeTMF to ensure compliance to International Conference of Harmonisation Guidelines for GoodClinical Practice (ICH/GCP) and AZ SOPs.
- Interact/collaborate with Site Management & Monitoring, other internal staff and externalvendors in 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 effectivepublishing and delivery to regulatory authorities. Proactively plan and collate theadministrative appendices for the CSR.
- Initiate and maintain production of study documents, ensuring template and versioncompliance per study specific requirements.
•Set-up, populate and accurately maintain information in AstraZeneca tracking andcommunication tools (e.g. IMPACT, SharePoint, BOX if used, MS teams and study team sharedmailbox) and support team members in the usage of these tools.•Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity inPharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meetthe 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 collection of study supplies, if required, at the study close-out. •Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs
- 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.
- Prepares, contribute and distribute presentation material for meetings, newsletters and web-sites.
- Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.
Requirements
Essential
- Education in medical or biological sciencesor discipline associated with clinicalresearch preferred;
- Proven organizational and analytical skills
- Previous administrative training/experience
- Computer proficiency in day-to-day tasks
- Develop working knowledge of the ClinicalStudy Process and an understanding of therange of working procedures relating to it,together with an understanding of theICH/GCP guidelines
- Excellent verbal and writtencommunication in English
- Demonstrate ability to work independently,as well as in a team environment
- Ability to prepare presentation materials
Desirable
- Bachelor level education (or higher)
- Proven study admin/assistant or relevantexperience on a study level
- Experience in clinical study lifecycle
