Global Study Associate, Oncology R&D, Early Oncology Clinical
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.
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:
Are you ready to make a difference in the world of oncology research? As a Global Study Associate, you'll play a crucial role in supporting the delivery of clinical studies by providing essential administrative and system support. With the opportunity to work across multiple studies, you'll need to be adaptable and flexible, ensuring that each study runs smoothly and efficiently. Dive into the dynamic world of clinical programs and contribute to groundbreaking research!
Accountabilities:
Collect, review, and track relevant study documents.
Support set-up, maintenance, closeout, and archiving of the Trial Master File (TMF). Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness.
Support production of study documents, ensuring template and version compliance and that relevant documents are ready for publishing in the regulatory document management system.
Set-up, populate, and accurately maintain information in tracking systems and communication tools. Support other study team members in the use of these systems.
Manage and contribute to the coordination and tracking of study materials and equipment.
Assist in the tracking and reconciliation of invoices.
Support study team and provide study metrics/reports during the study, audits, and regulatory inspections.
Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g., study team meetings, monitor meetings, investigator meetings, and advisory boards.
Liaise with internal and external participants and/or vendors. Track approvals and completion of required documents.
Prepare and distribute study-related correspondence. Contribute to and distribute material for meetings, newsletters, and websites.
Essential Skills/Experience:
University degree/bachelor’s degree, or equivalent experience
Good understanding of drug development
Minimum of 1-2 years’ experience of administrative/operational support of clinical studies
Desirable Skills/Experience:
Knowledge of ICH-GCP principles
Team-oriented
Ability to coordinate and prioritize multiple tasks and deliverables
Proactive approach
High degree of flexibility
Demonstrated verbal and written communication skills
Great People want to Work with us! Find out why:
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 emailing AZCHumanResources@astrazeneca.com.
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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.
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