Global Study Manager, Cell Therapy

Global Study Manager

In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Oncology R&D team tasked with supporting Clinical and Commercial production across multiple sites.

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation ultimately providing employees with the opportunity to work across teams, functions and even the globe.

As the Global Study Manager, you are a member of the extended global study team supporting the Cell Therapy department for delivery of clinical studies to time, cost and quality from Clinical Study Protocol (CSP) development through to study archiving. You will report to the Clinical Program Director and will be based in Gaithersburg, MD.

You will :

• Work cross-functionally building partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery.
• Maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other outside service providers to ensure an efficient study delivery.
• Lead and / or participate in the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc.) and external service provider related documents (e.g. specifications)
• Support the Global Study Associate Director (GSAD) in project management as per agreed delegation
• Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers
• Help support the GSAD with budget management, such as external service provider invoice reconciliation
• Make sure studies are inspection-ready at all times according to ICH-GCP, AZ SOP and relevant policies / guidelines
• Ensure that all study documents in scope of GSM's responsibilities are completed and verified for quality in the Trial Master File
• Assist with the planning and conduct of internal and external meetings (e.g. Investigator / Monitors meeting)
• Monitor study conduct and progress, identifying and resolving risks and issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the GSAD
• Contribute to ad hoc team productivity and efficiency by providing direction and facilitating positive team dynamics
• Have the opportunity to provide input into non-drug project work including training activities and the development of procedures as needed
• Be responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and SOPs

You have :

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.