Senior Global Study Manager - Cell Therapy
AstraZeneca

Job Info

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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
  
• 5 years Clinical Trial Experience
  
• 2 years in Global Study Management
  
• 3 years Cell Therapy Experience
  
• Excellent knowledge of ICH-GCP principles
  
• Experience in Oncology R&D is a plus.
  

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 experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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 follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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 recognising their potential. Join us on our journey of building a new kind of organisation 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.

So, what's next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.

Where can I find out more?

Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd

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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.

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