12 months fixed term/secondment

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, 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 behaviors.

Responsibilities:

• 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 to International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.

• Interact/collaborate with Site Management & Monitoring, other internal staff and external vendors in collection of regulatory and other essential documents.

• Contribute to electronic applications/submissions 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 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 fulfil AstraZeneca compliance and meet the regulatory authority needs.

• Support the GSD/GSAD with tracking, reconciliation and follow-up of the study budget/ payments in relevant systems.

• 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 sciences or discipline associated with clinical research preferred;

• Proven organizational and analytical skills

• Previous administrative training/experience

• Computer proficiency in day-to-day tasks

• Develop 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 guidelines

• Excellent verbal and written communication in English

• Demonstrate ability to work independently, as well as in a team environment

• Ability to prepare presentation materials

• Demonstrate professionalism and mutual respect

• Willingness and ability to train others on study administration procedures

• Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high- volume environment with shifting priorities

Desirable:

• Bachelor level education (or higher)

• Proven study admin/assistant or relevant experience 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.