Global Study Associate

At AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledge-sharing ambitious thinking and innovation ultimately providing employees with the opportunity to work across teams functions and even the globe.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people the planet and our business are interconnected which is why were taking ambitious action to tackle some of the biggest challenges of our time from climate change to access to healthcare and disease prevention.

The Role:

TheGlobal Study Associateis a member oftheglobal study team supporting delivery of clinical studieswithinBioPharmaceuticals ClinicalOperations Study Managementtotime cost and quality.

TheGSAsupports delivery of global clinical studies from study set-up through maintenance close-out and study archiving. The GSA supports the Global Study Director (GSD) Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities ensuring quality and consistency. The GSA supports with administration & systems and with other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations (ex. ICH-GCP) AstraZeneca (AZ) Standard Operating Procedures (SOPs) AZ policies & best practices and AZ values & behaviours.

Typical Accountabilities:

• Support GS(A)D andGSMs by completing delegated study work. May work across many different studies and delivery models concurrently.

• 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 Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.

• Provide oversight for non-complex non-critical path vendors ensuring compliance with study requirements andestablishedprocesses.

• Interact/collaborate with internal staff and externalstakeholdersin collection of regulatory and other essential documents.

• Contribute to electronic applications/submissions inregulatoryinformationmanagementsystem bycreating and managing clinicalregulatory 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.

• Initiatemaintainand/or support thecreationof study documents ensuring template and version compliance per study specific requirements.

• Set-up populate and accuratelymaintaininformation in AstraZeneca tracking and communication tools and support team members in the usage of these tools.

• Support the set-upmaintenanceand close-out of Clinical Trial Transparency (CTT) activity inPharmaCM coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs.

• Support the GS(A)D with trackingreconciliationand follow-up of the study budget/payments inrelevant systemsincludingthecreation and maintenance of purchase orders running invoice and payment reports.

• Contribute to application coordination supply and tracking of study materials and equipment.

• Contribute to collection of study supplies ifrequired at the study close-out.

• Coordinateand provide oversightofadministrative tasks and logisticalsupportthroughout the conduct of the studyauditsand regulatory inspections according to company policies and SOPs.

• Lead thecoordination andcontribute to the preparation of internal and external team meetings committee meetingsmonitormeetings Investigatormeetingsand virtual meetings. Liaise with internal and external participants and/or vendors.

• Preparecontributeand distribute presentation material for meetingsnewslettersand websites.

• Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

• Other duties as assigned and within scope of role.

Essential Experience:

• Bachelor level education with at least 2 years experience in in medical or biological sciences or discipline associated with clinical researchpreferred

• Proven study admin/assistant or relevant experience on a study level with experience in clinical study lifecycle

• Proven organizational and analytical skills

• Previousadministrative training/experience

• Computerproficiencyin 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 presentationmaterials

• 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

Are you interested in working at AZ apply today!

AstraZenecais an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment assessment and selection process and may be requested by emailing.

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Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.