Global Study Associate

About the role

AstraZeneca's Global Study Associate is part of the global study team in BioPharmaceuticals Clinical Operations, Study Management, supporting delivery of clinical studies to time, cost and quality. The role covers study set-up through maintenance, close-out and archiving, and supports the Global Study Director, Global Study Associate Director and/or Global Study Manager in coordinating activities and ensuring quality and consistency.

Key responsibilities

• Complete delegated study work and work across many studies and delivery models at once
• Initiate and lead the electronic Trial Master File (eTMF), maintain and close it in line with ICH/GCP and AZ SOPs
• Oversee non-complex, non-critical-path vendors and collect regulatory and other essential documents with internal and external stakeholders
• Create and manage clinical regulatory documents in the regulatory information management system and prepare administrative appendices for the CSR
• Maintain study documents and AstraZeneca tracking and communication tools
• Support Clinical Trial Transparency (CTT) in PharmaCM and track, reconcile and follow up the study budget and payments, including purchase orders and invoices
• Help coordinate study materials, supplies and logistics during audits and regulatory inspections, and run study, committee, monitor and investigator meetings
• Prepare presentation material and contribute to non-drug process-improvement projects

Required profile

• Educated in medical or biological sciences or a related clinical research discipline (bachelor's degree preferred)
• Previous administrative training or experience, and proven organizational and analytical skills
• Working knowledge of the clinical study process and ICH/GCP guidelines
• Excellent English communication, independent and team-working ability, and willingness to train others
• Desirable: study admin/assistant experience and clinical study lifecycle experience

Required skills

• Computer proficiency in day-to-day tasks
• Organization, time management, attention to detail and multitasking in a high-volume environment