Global Study Manager (12 - Month Contract)
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 Manager, you'll play a pivotal role in supporting the delivery of clinical studies with a focus on quality and compliance. This dynamic position requires flexibility and adaptability to meet the unique demands of each clinical program. Are you up for the challenge?
Accountabilities:
Contribute to the development and updates of study documents, ensuring compliance with templates and versions.
Lead the preparation of country-specific agreements, confidentiality agreements, clinical trial applications, and other relevant documents.
Manage third-party vendor setup, including initial statement of work, budget assessment, and change order processes.
Provide input to data management documents and collaborate with data management representatives and sites for effective study data delivery.
Initiate contract/budget requests, track status, facilitate purchase orders, review vendor invoices, and monitor spending against approved budgets.
Ensure the supply of investigational products and study materials by liaising with Drug Supply or external service providers.
Oversee third-party vendors, global/local internal staff, and investigator sites to support study delivery from protocol development to Clinical Study Report.
Provide oversight and support for recruitment, data delivery, and risk mitigation strategies.
Assist in the clinical trial insurance process; track approvals, revisions, and renewals of certificates.
Monitor study conduct and progress, proactively resolving issues impacting study quality, timelines, or budget.
Support risk management and quality efforts to ensure study compliance.
Support set-up, maintenance, closeout, and archiving of the Trial Master File (TMF), ensuring inspection readiness.
Prepare presentation materials for meetings, newsletters, and websites.
Support the study team in audits and regulatory inspections.
Contribute to the review of new/amended/unique SOPs and guidance documents.
Essential Skills/Experience:
University degree/Bachelor’s degree in medical or biological science or discipline associated with Clinical Research, or equivalent experience
Minimum of 3-4 years of progressive clinical trial experience
United States only: Bachelor's Degree and 3+ years of experience, Associate's degree plus 7+ years of experience or High School plus 11+ years of experience
Experience working with and delivering through strategic partners and 3rd party vendors
Excellent 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
Good negotiation and collaboration skills
Demonstrated interpersonal and problem-solving skills
Some travel may be required
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.
#LI-Hybrid
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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