Global Study Manager, Oncology R&D, Early Oncology Clinical

Introduction to role Are you ready to make a difference in the world of clinical 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 as you navigate the unique challenges of each clinical program. Accountabilities Contribute to the development and updates of study documents, ensuring template and version compliance. Lead the preparation of country-specific agreements, confidentiality agreements, clinical trial applications, and other applicable country documents. Manage the setup of third-party vendors, assessing initial statements of work and budgets, and overseeing the change order process. Provide input to data management documents and collaborate with data management representatives and sites to facilitate study data delivery. Initiate contract/budget requests, track ongoing status, facilitate purchase orders, review vendor invoices, and assist in tracking spend against approved budget. 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 effective 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 identifying and resolving issues impacting study delivery. Support risk management and quality efforts to ensure study compliance. Support setup, maintenance, closeout, and archiving of the Trial Master File (TMF), ensuring continual inspection readiness. Prepare presentation material for meetings, newsletters, and websites. Support the study team in implementing 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 Desirable Skills/Experience Early phase oncology clinical trial experience Global study management experience Great People want to Work with us Find out why GTAA Top Employer Award for 10 years Top 100 Employers Award Canada’s Most Admired Corporate Culture Learn more about working with us in Canada View our YouTube channel 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. Date Posted 23-Dec-2025 Closing Date 01-Jan-2026 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. #J-18808-Ljbffr