Global Study Leader, Oncology
Mississauga, Head Office
The Global Study Leader (GSL) is 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
- 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.) lead study level performance against agreed upon plans, and 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
- 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 (preferable 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
- You possess strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, empowering critical thinking, problem solving, and influencing
- You have experience with 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:
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- 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
Our purpose is bold and so is our approach. Becoming a more agile and innovative company means building a vibrant, dynamic culture where we celebrate entrepreneurial thinking and acting quickly. We are courageous, trying new things and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver medicines.
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 authorisation and employment eligibility verification requirements.