Global Study Manager, Cell Therapy

Job Description

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.

WHY JOIN US?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

SO, WHAT’S NEXT?

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 11 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].

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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.