Senior Global Study Leader, Oncology
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 a significant 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, inspiring 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 succeeding. 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 create and deliver medicines.
Position Title: Senior Global Study Leader, Oncology
Position Type: 1 year Temporary Contract (For internals 1 year Secondment)
Location: Mississauga, Head Office
Career Level: F
The Senior Global Study Leader (SGSL) is a business-critical role within Late Stage Oncology Study Management Operations whose main accountability is the operational planning, budget management, and delivery of high priority and complex clinical studies.
- Lead and coordinate a team in accordance with STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of timelines, budget and quality standards
- Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight
- Collaborate with other functions to establish strategies and identify common practices aimed at improving efficiency of global study teams
- For outsourced studies, be the primary AZ point of contact for the CRO Study Manager to ensure study delivery, including oversight of the CRO throughout the lifecycle of the study, following relevant AZ SOPs and guidelines (e.g. description of services and transfer of obligations)
- Provide operational expertise into and hold accountability for the development of crucial study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)
- Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
- Develop and maintain relevant study plans including study level quality and risk management planning with risk response strategies and clear issue resolution pathways
- Oversee study level performance against agreed upon plans, timelines and key performance indicators (quality and operational) by using company tracking systems and project timelines, while communicating any risks to timelines and/or quality to CPT, along with proposed mitigations
- Oversee Trial Master File (TMF) completion including ensuring the TMF plan and Expected Document List are in place and that QC activities are performed on an ongoing basis
- Ensure timely compliance with company-wide governance controls and that studies are inspection-ready at all times, according to relevant policies/guidelines
- Support professional development of team through feedback on performance, mentoring and empowering colleagues
- 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 associated with clinical research
- Previous project management experience and able to lead multiple priorities
- At least 7 years of clinical trial experience in all phases of study delivery and relevant guidelines and regulatory requirements, preferably in Oncology
- Proven experience in global study leadership and team leadership with practice of mentoring and empowering a team
- Strong strategic and critical thinking skills with strong resolution management skills
- Excellent communication and interpersonal skills
- Experience in external provider oversight and management
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
Are you interested in working at AZ? Apply today!
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 follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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.