Senior Global Study Manager, Cell Therapy
The Senior Global Study Manager, Cell Therapy leads the operational activities to support and help the delivery of cell therapy clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the nature of the clinical program or clinical study. You will report to the Director, Study Leader, Cell Therapy.
You Will:
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.
Manage the set-up of third-party vendors, assessing initial statement of work and budget, and the change order process.
Provide input to data management documents and interface with data management representatives and sites to help deliver study data.
Initiate contract/budget requests and track 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 collaborating with Cell Therapy Operations (CTO) or external service providers.
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.
Oversee the clinical trial insurance process, track approvals, revisions, and renewals of certificates.
Monitor study conduct and progress, proactively identifying and 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.
Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring inspection readiness.
Prepare presentation material for meetings, newsletters, and websites.
Direct the Study Team in the implementation of audits and regulatory inspections.
Identify areas of best practice / process improvements and knowledge share across the Cell Therapy Clinical Group.
Contribute to review of new/amended/unique SOPs and guidance documents.
You Have:
Bachelor's degree, preferably in medical or biological science, or discipline 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
Experience working with and delivering through strategic partners and 3rd party vendors
Excellent knowledge of ICH-GCP principles
Lead, coordinate multiple tasks and deliverables
Achieve study goals and collaboration skills
Seek and advocate for more efficient ways of working
Coach & act as a buddy for more junior colleagues
Some travel may be required
Early phase oncology clinical trial experience
Experience in autologous or allogeneic oncology therapies
The annual base salary for this position ranges from $136,000 to $204,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Our Benefits:
Benefits offered include:
A qualified retirement program [401(k) plan]
Paid vacation, holidays, and paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
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Date Posted
18-Jul-2025Closing Date
24-Jul-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.