Senior Global Study Manager

4 weeks ago

Waltham, United States AstraZeneca Full time

The Senior Global Study Manager, Cell Therapy is responsible for leading the operational activities to support and enable 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, so a high degree of flexibility is required.

Typical Accountabilities Provide operational expertise to the Study Team. Lead the development of study documents as well as 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 effective collaboration and communication with the Study Team. Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process. Provide input to data management documents and interface with data management representatives and sites to facilitate the delivery of study data. Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget. Ensure the supply of study materials and ensure the appropriate allocation of apheresis/manufacturing slot availability by liaising 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 effective delivery of a study and its regulatory documents. Provide oversight of and support recruitment and data delivery as well as 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 impact delivery of the study to the necessary quality, timelines, or budget. Drive risk management and quality efforts to ensure study compliance. Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual 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.

Education, Qualifications, Skills, and Experience Essential Bachelor's Degree and 5+ years of experience, Associate's degree plus 9+ years of experience or High School plus 13+ years of experience, of which at least 2 years are in global study management. Experience of working with and delivering through strategic partners and 3rd party vendor Excellent knowledge of ICH-GCP principles. Team orientated. Ability to lead, coordinate and prioritise multiple tasks and deliverables. Proactive approach to achieving study goals. Demonstrated verbal and written communication skills. Good negotiation and collaboration skills. Demonstrated interpersonal and problem- solving skills. Ability to manage change and actively seek and champion more efficient and effective ways of working. Ability to coach & act as a buddy for more junior colleagues. Some travel may be required.

Desirable Early phase oncology clinical trial experience. Experience in autologous or allogeneic oncology therapies

Date Posted 26-Apr-2024 Closing Date 23-May-2024Our 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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law. #J-18808-Ljbffr

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