Step into the world of AstraZeneca’s Cell Therapy division, where science meets innovation to tackle some of the globe’s most challenging diseases. Our mission is to treat, prevent, modify, and even cure these conditions, expanding our pipeline to make a global impact on patient lives. As part of the Oncology R&D team, you will support clinical and commercial production across multiple sites, driving breakthroughs by merging data and technology with scientific advancements. At AstraZeneca, we foster a collaborative culture that encourages knowledge-sharing, ambitious thinking, and innovation, offering employees the chance to work across teams, functions, and continents.

ACCOUNTABILITIES:

• As the Global Study Manager, you’ll be an integral member of the extended global study team within the Cell Therapy department, ensuring clinical studies are delivered on time, within budget, and with high quality from Clinical Study Protocol development through to study archiving. Reporting to the Clinical Program Director in Gaithersburg, MD, your responsibilities will include:
• Building partnerships with internal and external partners to ensure successful study delivery.
• Facilitating interactions with internal functions like Data Management and external functions such as CROs for efficient study delivery.
• Leading or participating in the preparation of study documents and external service provider-related documents.
• Supporting the Global Study Associate Director in project management.
• Ensuring the supply of study materials and Investigational products.
• Assisting with budget management and invoice reconciliation.
• Maintaining inspection-ready studies according to ICH-GCP, AZ SOP, and relevant policies/guidelines.
• Completing and verifying quality of study documents in the Trial Master File.
• Assisting with planning and conducting internal and external meetings.
• Monitoring study conduct and progress, resolving risks and issues with the GSAD.
• Contributing to team productivity and efficiency by facilitating positive team dynamics.
• Providing input into non-drug project work including training activities and procedure development.
• Collecting and reporting Adverse Events in accordance with guidelines.

ESSENTIAL SKILLS/EXPERIENCE:

• Bachelor’s degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• Minimum 5 years’ experience within the pharmaceutical industry supporting clinical operations.

DESIRABLE SKILLS/EXPERIENCE:

• Project management, organizational and analytical skills.
• Knowledge of clinical development/drug development process across various phases and therapy areas as well as relevant knowledge of international guidelines ICG-GCP.
• Previous Cell Therapy experience is a plus.

Please refer the Job description for details