Global Study Associate (permanent/12 month secondment/fixed-term)

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 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 ittogether with an understanding of theICH/GCP guidelines
Excellent verbal and writtencommunication in English
Demonstrate ability to work independentlyas 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

Date Posted

Closing Date

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. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.