Senior Global Study Manager - Cell Therapy

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

At AstraZeneca's Oncology R&D 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. Here we have the potential to grow our pipeline and positively impact the lives of billions 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.

Position Summary

The Senior Global Study Manager, Cell Therapy leads the operational activities to support and ensure the delivery of cell therapy clinical studies ensuring quality and compliance. The accountabilities will differ depending on the nature of the clinical program or clinical study.

Responsibilities

Provide operational expertise to the Study Team.

• Lead the development of study documents and any updates/amendments, ensuring template and version compliance.

• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.

• Provide mentoring and guidance to the operations team ensuring collaboration and communication with the Study Team.

• Provide input to data management documents and collaborate with data management representatives and sites to help deliver study data.

• Initiate contract/budget requests and supervise ongoing status; facilitate generation of purchase orders, review vendor invoices and help track spend against approved budget.

• Ensure the supply of study materials and ensure the appropriate allocation of apheresis/manufacturing slot availability by partnering with Cell Therapy Operations (CTO) or external service providers as appropriate.

• Oversight of third-party vendors, global / local internal staff, and investigator sites to support delivery of a study and its regulatory documents.

• Provide oversight of and support recruitment and data delivery and risk mitigation strategies.

• Be responsible for the clinical trial insurance process, track approvals, revisions, and renewals of certificates.

• Monitor study conduct and progress, resolving issues which may affect delivery of the study to the necessary quality, timelines, or budget.

• Guide risk management and quality efforts to ensure study compliance.

• Lead set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring inspection readiness.

• Prepare presentation material for meetings, newsletters, and websites.

• Advise the Study Team in the implementation of audits and regulatory inspections.

• Identify areas of standard methodology / process improvements and knowledge share across the Cell Therapy Clinical Group.

• Contribute to review of new/amended/outstanding SOPs and mentorship documents.

Experience and Education

• Bachelor's degree in medical or biological science, or field associated with Clinical Research, or equivalent experience.

• Minimum of 5 years clinical trial experience, of which at least 2 years are in global study management United States only.

• Bachelor's degree and 5+ years, Associate's degree plus 9+ years or High School plus 13+ years of experience, of which at least 2 years are in global study management.

• Excellent knowledge of ICH-GCP principles.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and bold world.

The annual base salary for this position ranges from $126,000 to $174,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related exp