Global Study Associate

Experteer Overview

You contribute to regulatory submissions and study materials, enabling compliant, efficient study execution. This position offers exposure to diverse studies, process improvements, and a path to greater responsibility within Clinical Operations.

• Support GS(A)D and GSMs by completing delegated study work across multiple studies and delivery models
• Initiate and lead eTMF set-up and maintain/close to ensure ICH-GCP and AZ SOP compliance
• Provide oversight for non-complex vendors and ensure process compliance
• Collaborate with stakeholders to collect regulatory and essential documents
• Contribute to regulatory information management submissions and publish to authorities
• Prepare administrative appendices for CSR and manage study documents with template/version control
• Maintain AstraZeneca tracking and communication tools and train team members
• Support Clinical Trial Transparency activities in PharmaCM and regulatory compliance
• Track budgets/payments in relevant systems, create POs, and generate invoices
• Coordinate study materials/equipment, and assist with study close-out supplies
• Coordinate administrative tasks for audits/regulatory inspections and meetings
• Prepare and distribute meeting materials and presentations
• Engage in process improvement projects and other duties as assigned

• Proven organizational and analytical skills
• Administrative training/experience
• Computer proficiency for day-to-day tasks
• Understanding of Clinical Study Process and ICH/GCP
• Excellent English communication, both verbal and written
• Ability to work independently and in a team
• Ability to prepare presentation materials
• Professionalism and mutual respect
• Willingness to train others on study administration procedures
• Strong organization, time management, attention to detail, and multitasking in a high-volume environment

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