Global Study Manager, Haematology CAR-T

at  Alexion PharmaceuticalsInc

ESSENTIAL QUALIFICATIONS/ EXPERIENCE

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
• Minimum 3 years experience within the pharmaceutical industry supporting clinical operations
• Haematology/Oncology experience
• Shown project management, organizational and analytical skills
• Knowledge of clinical development / drug development process across various phases and therapy areas as well as relevant knowledge of international guidelines ICG-GCP
• Global clinical research experience in managing multiple countries
• CAR-T experience
• Vendor management
• Sponsor experience or having worked in a Functional Service Provider (FSP) model previously for another sponsor

• You are a member of the extended global study team supporting delivery of clinical studies to time, cost and quality from Clinical Study Protocol (CSP) development through to study archiving.
• You will work cross-functionally building partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery
• You will 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.
• You will 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)
• You will support the Global Study Associate Director (GSAD) in project management as per agreed delegation
• You ensure the supply of study materials and Investigational product by collaborating closely with Clinical Supply Chain or external service providers
• You help support the GSAD with budget management, such as external service provider invoice reconciliation
• You make sure studies are inspection-ready at all times according to ICH-GCP, AZ SOP and relevant policies/guidelines
• You will ensure that all study documents in scope of Global Study Manager’s (GSM) responsibilities are completed and verified for quality in the Trial Master File
• You will assist with the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)
• You will monitor study conduct and progress, identifying and resolving risks and issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the GSAD
• You will contribute to ad hoc team productivity and efficiency by providing direction and facilitating positive team dynamics
• You will have the opportunity to provide input into non-drug project work including training activities and the development of procedures as needed
• You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and SOPs