Global Study Manager, Cell Therapy

Introduction to role:

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.

Date Posted

22-Jul-2024

Closing Date

01-Aug-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.