Are you ready to unleash your imagination and follow the science? Join us as a Global Study Manager in Cell Therapy, where you will lead operational activities to support and ensure the delivery of cell therapy clinical studies. This role is pivotal in maintaining quality and compliance, with accountabilities varying depending on the nature of the clinical program or study. This is your chance to be part of our Oncology R&D team, where we are dedicated to eliminating cancer as a cause of death.
Accountabilities:
As a Global Study Manager, you will provide operational expertise to the Study Team, lead the development of study documents, prepare country-specific agreements, mentor the operations team, and lead all aspects of third-party vendors. You will also monitor study conduct and progress, guide risk management efforts, lead the setup and maintenance of the Trial Master File (TMF), and advise the Study Team in the implementation of audits and regulatory inspections. Your role will also involve identifying areas of standard methodology/process improvements and contributing to the review of new/amended/outstanding SOPs.
Essential Skills/Experience:
Bachelor's degree in medical or biological science, or field associated with Clinical Research, or equivalent experience.
Minimum of 5 years clinical trial experience, of which at least 2 years are in global study management.
Excellent knowledge of ICH-GCP principles.
Experience in Oncology or Cell Therapy.
Proven track record managing complex projects and meet deliverables.
Strong communication and leadership skills.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
At AstraZeneca, we follow the science. This core value guides our decision-making at every level. Our teams are encouraged to push the boundaries of science with no limits to our curiosity. We make bold moves at the cutting edge, transforming molecules to change the practice of medicine. Since our renewed focus on building our Oncology function, we have had great successes with 7 new Oncology medicines since 2013. We set the tone for the rest of the industry, consistently publishing our findings in high impact journals, and leading with expertise and entrepreneurial spirit. And we continue to push forward. In 2019 we invested $6.1bn in Research & Development.
Are you ready to pioneer new frontiers? Join us in our mission to eliminate cancer as a cause of death. Apply today to be part of a team committed to improving the lives of millions with cancer.
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.
