Global Study Associate

Responsibilities

Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) by completing delegated study work; Initiate and lead the set-up of the electronic Trial Master File (eTMF), maintain and close the eTMF to ensure compliance to ICH/GCP and AZ SOPs; Collaborate with Site Management & Monitoring, extended study team and external vendors in collection of regulatory and other essential documents; Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness; Contribute to electronic applications/submissions by creating and managing clinical-regulatory documents; Initiate and maintain production of study documents, ensuring template and version compliance; Set-up, populate and accurately maintain information in tracking and communication tools; Support set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM; Support GSD/GSAD with tracking, reconciliation and follow-up of study budget/payments; Contribute to application, coordination, supply and tracking of study materials; Coordinate administrative tasks and logistic support throughout the study, audits and regulatory inspections; Lead practical arrangements coordination and contribute to preparation of internal and external meetings

Requirements

Proven organizational and analytical skills; Previous administrative training/experience; Computer proficiency in day-to-day usage; Working knowledge of the Clinical Study Process and understanding of ICH/GCP guidelines; Excellent verbal and written communication in English; Ability to work independently and in a team environment; Willingness and ability to train others on study administration procedures; Experience managing eTMF and CTMS systems

Nice to have

Education in medical or biological sciences or discipline associated with clinical research; Global study support experience; Veeva Vault experience

Benefits

Various annual leave entitlements; A range of health insurance offerings; Competitive retirement planning offerings; Global Employee Assistance Programme, LifeWorks; Life assurance; Flexible country-specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments