Global Study Associate Director
Are you passionate about leading clinical trials and drug development? Be part of the team that follows the science to transform the lives of patients living with cancer. There is no better place to make an impact, join AstraZeneca today!
AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
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 commitment 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 bold action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Oncology 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 Oncology team that’s 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’ll 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 archiving
Mentor 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 SOPs
Be 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 studies
Develop 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 appropriate
Provide 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 services
Ensure 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 Meetings
Set initial operational study budget with the Clinical Program Team (CPT), and are responsible for study budget throughout the study, providing budget progress reports to leadership
Ensure studies are inspection-ready at all times, according to ICH-GCP, AZ SOP and relevant policies/guidelines
Responsible for the completeness of the Trial Master File; being the primary Study Management point-of-contact in the event of an audit or inspection
May 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 work
You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures
Essentials 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 areas
A 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 influencing
Significant experience managing study budgets
Strong communication skills with the ability to build positive relationships, including vendor leadership skills
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 8 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada
- Best Workplace Culture Award at the 2018 Canadian HR Awards:https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
- Learn more about our culture:https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G
- Browse AstraZeneca's Oncology YouTube channel to find out more about our focus:https://www.youtube.com/playlist?list=PLgfkdJlwmkT7Sj9A_N6J_9OKcnBW5eNyy
Are you interested in working at AZ, apply today!
AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.
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.
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.