Astrazeneca
Cell Therapy
GlobalStudyManager
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“Global Study Manager at Astrazeneca. Skills: Clinical study delivery, Cross-functional collaboration, Study document preparation, Study conduct monitoring. Deliver clinical studies to time, cost and quality. Build partnerships with internal and external partners”
What You'll Achieve.
Successful study delivery; Efficient study delivery; Study delivery to quality; Study delivery to timeline; Study delivery to budget objectives
Industry & Context.
Analytical skills; Identifying and resolving risks; Identifying and resolving issues
What They're Looking For.
Must Have
Bachelor's degree, Minimum 5 years' experience within the pharmaceutical industry supporting clinical operations, Project management skills, Organizational skills, Analytical skills, Knowledge of clinical development / drug development process, Knowledge of international guidelines ICG-GCP
Nice to Have
Previous Cell Therapy experience
What You'll Do.
Deliver clinical studies to time
Build partnerships with internal and external partners
Provide oversight for study delivery
Facilitate interactions with internal functions
Facilitate interactions with external functions
Lead preparation of delegated study documents
Participate in preparation of delegated study documents
Support GSAD in project management
Ensure supply of study materials
Ensure supply of Investigational product
Support GSAD with budget management
Ensure studies are inspection-ready
Complete and verify study documents
Assist with planning internal meetings
Assist with planning external meetings
Monitor study conduct and progress
Identify and resolve study risks
Identify and resolve study issues
Provide direction to team
Facilitate positive team dynamics
Collect Adverse Events
Report Adverse Events
How You'll Work.
Team & Collaboration
Work cross-functionally building partnerships; Collaborative culture; Knowledge-sharing; Work across teams, functions and globe
Process & Methodology
Project management, Organizational skills, Analytical skills, Support GSAD in project management, Budget management
Full Job Description
**WE ARE BUILDING PIPELINE OF CANDIDATES - THIS IS NOT ACTIVE RECRUITMENT** In AstraZeneca's Cell Therapy 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. We have the potential to grow our pipeline and positively impact the lives 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. This role is part of the Oncology R&D team tasked with supporting Clinical and Commercial production across multiple sites. At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. As the Global Study Manager, you are a member of the extended global study team supporting the Cell Therapy department for delivery of clinical studies to time, cost and quality from Clinical Study Protocol (CSP) development through to study archiving. You will report to the Clinical Program Director and will be based in Gaithersburg, MD. **You will:** * Work cross-functionally building partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery. * Maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other outside service providers to ensure an efficient study delivery. * Lead and/or participate in the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc.) and external service provider related documents (e.g. specifications) * Support the Global Study Associate
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