Global Study Manager, Cell Therapy

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.

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, support risk management and quality efforts, and assisting in the implementation of audits and regulatory inspections. You will be based in Gaithersburg, MD and will report to the Director, Study Management Cell Therapy.

Essential Qualifications:

• Bachelor’s degree with 4+ years of experience as a study manager

• Experience of working with and delivering through strategic partners and 3rd party vendors

• Excellent knowledge of ICH-GCP principles

• Ability to lead, coordinate and prioritize multiple tasks and deliverables

• Vendor Management experience

• 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 Experience:

• Early/late phase oncology clinical trial experience

• Experience in autologous or allogeneic therapies

• Clinical Study Management experience

#CellTherapy

The annual base pay for this position ranges from $112K to $168K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

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. 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. You can 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!

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering innovative methods and bringing unexpected teams together. Interested? Come and join our journey.

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.