Job Description

Global Study Associate Director, HaematologyHybrid Work- 3 days/week from our Mississauga, ON officeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 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 is 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\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.Our Haematology Research and Development TeamClinical research is driven by speed. Here you will be backed by leadership and empowered at every level to prioritize and make bold moves. Our pioneering approach is identifying and treating patients earlier, focusing on early stage cancer trials and listening and evolving based on their needs.Join a dedicated Haematology team that\xe2\x80\x99s growing fast and building a strong track record of success. We make bold moves at the cutting-edge. Transforming molecules to change the practice of medicine.What you\xe2\x80\x99ll do:Responsible for leading a cross-functional study team to enable successful delivery of clinical studies from the onset of study specifications through to study archivingMentor and empower a cross-functional team to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality in line with ICH/GCP and AZ relevant SOPsBe the key point of contact to the CRO project manager to ensure delivery to time, quality and cost; ensuring AZ oversight of the CRO is defined and performed across relevant AZ functions for outsourced studiesDevelop and maintain up to date study plans (e.g. global study management plan, monitoring plan, etc.) ensure study level performance against agreed upon plans, lead proactive risk and contingency planning and raise issues as appropriateProvide input and hold accountability for the development of crucial study level documents (i.e. Clinical study Protocol)Select and lead vendors, handling their performance to ensure high quality, timely delivered servicesEnsure appropriate training is provided to the local teams, investigators and site staff as well as vendor teams as needed; taking an active role in the Investigators/Monitoring MeetingsSet initial operational study budget with the Clinical Program Team (CPT), and are responsible for study budget throughout the study, providing budget progress reports to leadershipEnsure studies are inspection-ready at all times, according to ICH-GCP, AZ SOP and relevant policies/guidelinesResponsible for the completeness of the Trial Master File; being the primary Study Management point-of-contact in the event of an audit or inspectionMay be assigned responsibility for leadership or participation in non-drug project work including applying process improvements methods and to inspire change for new ways to workYou are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and proceduresEssentials for the role:University degree (or equivalent), preferably in medical or biological sciences or related to clinical research. Advanced degree is preferred.At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including clinical trial leadership experience (preferably on global trials)Solid understanding of clinical operations and study management processes, along with experience in various phases of development and therapy areasA minimum of 2 years clinical project management experience. PMP certification is desirable.Possess strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, empowering critical thinking, problem solving, and influencingSignificant experience managing study budgetsStrong communication skills with the ability to build positive relationships, including vendor leadership skillsGreat 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 .Date Posted 10-Sept-2024Closing Date 26-Sept-2024AstraZeneca 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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