Global Study Manager - Cell Therapy, Oncology R&D at AstraZeneca in Gaithersburg, Maryland

Job Description:

Introduction to role:


Are you ready to make a bold move in your career? Join us as a Global Study Manager in Cell Therapy, where you will be responsible for supporting the delivery of cell therapy clinical studies ensuring quality and compliance. This role requires a high degree of flexibility as the exact accountabilities will differ depending on the nature of the clinical program or study.


Accountabilities:
As a Global Study Manager, you will contribute to the development of study documents, lead the preparation of country-specific agreements, manage third-party vendors, provide input to data management documents, and ensure the supply of study materials. You will also oversee third-party vendors, global / local internal staff, and investigator sites to support effective delivery of a study. Your role will involve monitoring study conduct and progress, supporting risk management and quality efforts, and assisting in the implementation of audits and regulatory inspections.


Essential Skills/Experience:
- Bachelor's Degree and 3+ years of experience, Associate's degree plus 7+ years of experience or High School plus 11+ years of experience
- Experience of working with and delivering through strategic partners and 3rd party vendors
- Excellent knowledge of ICH-GCP principles
- Team orientated
- Ability to lead, coordinate and prioritise multiple tasks and deliverables
- Proactive approach to achieving study goals
- Demonstrated verbal and written communication skills
- Good negotiation and collaboration skills
- Demonstrated interpersonal and problem-solving skills
- Ability to manage change with a high degree of flexibility
- Some travel may be required


Desirable Skills/Experience:
- Early phase oncology clinical trial experience
- Experience in autologous or allogeneic therapies
- Clinical Study Management experience


At AstraZeneca, we follow the science and pioneer new frontiers. Our Oncology R&D team is dedicated to eliminating cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.


We are pioneers of collaborative research and have built an unrivalled scientific community both internally and externally. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers. Have the opportunity to build a rewarding and meaningful career as part of the team committed to improving the lives of millions with cancer.


Ready to make a difference? Apply now and join us in our mission to eliminate cancer as a cause of death!


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.