Global Study Leader, Biopharmaceuticals
At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make an important difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.
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 act with a sense of urgency. We are courageous, taking risks 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.
Position Title: Global Study Leader, Biopharmaceuticals
Position Type: Full-time, Temporary (12 Month Contract)
Location: Mississauga, Head Office
Career Level: E
Are you passionate about leading a team? The Global Study Leader (GSL) is responsible for leading a cross-functional study team and for providing the team with direction and clear decisions to enable successful delivery of clinical studies from receiving study specifications through to study archiving.
- You will lead a cross-functional team of experts 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
- As AZ’s project leader, you are the point of contact to the CRO project manager to ensure delivery to time, quality and cost; ensuring that appropriate AZ oversight of the CRO is defined and performed across relevant AZ functions for outsourced studies.
- You will 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 to stakeholders as appropriate
- You provide input and hold accountability for the development of essential study level documents (i.e. Clinical study Protocol)
- You lead, mentor and support the study team members
- You select and lead vendors, handling their performance to ensure high quality, timely delivered services
- You 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;
- You 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 CPT
- You will ensure studies are inspection-ready at all times, according to ICH-GCP, AZ SOP and relevant policies/guidelines
- You will be 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
- You may be assigned responsibility for leadership or participation in non-drug project work including applying process improvements methods and change management techniques
- 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 discipline associated with 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)?
- Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas
- A minimum of 2 years clinical project management experience. PMP certification is desirable but not mandatory.
- You possess strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing
- You have proven understanding of clinical study budget management
- Good communication and relationship building skills, including vendor management skills
Are you interested in working at AZ? Apply today
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager will know that you feel well qualified for this position. If you know someone who would excel in this position, you are invited to share this posting with them.
AstraZeneca is an equal opportunity employer. We will consider all applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Great People want to Work with us, find out why:
- GTAA Top Employer Award for 6 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
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.