Global Study Associate - 12 Months Contract

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.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

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 we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Introduction to role:

The Global Study Associate (GSA) is an integral member of the extended global study team, supporting the delivery of clinical studies within Late Development Oncology (LDO). This role ensures studies are completed on time, within budget, and to the highest quality standards. From the development of Clinical Study Protocols (CSP) through to study set-up, maintenance, close-out, and the creation of Clinical Study Reports (CSR), the GSA plays a crucial role in every phase of the study lifecycle. 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 AstraZeneca's Project Management Framework, clinical trial regulations, 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 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.
• Prepare, contribute to, 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 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 Skills/Experience:

• Bachelor level education (or higher)
• Proven study admin/assistant or relevant experience on a study level
• Experience in clinical study lifecycle
• External Service Providers, e.g., CRO, CISCRP

Are you interested in working at AZ, apply today!

AstraZeneca is 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 emailingAZCHumanResources@astrazeneca.com.

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