16 oct
|
AstraZeneca
|
Barcelona
16 oct
AstraZeneca
Barcelona
Experteer Overview As Global Study Associate you support late-stage oncology trials, helping deliver studies on time, budget, and quality. You collaborate with study leadership and cross-functional teams to manage study documents, regulatory submissions, and trial transparency activities. You drive eTMF setup, maintenance, and close-out, and support CSR preparation and budget tracking. Your work enables compliant, efficient study execution within AZ’s framework, SOPs, and ICH/GCP guidelines. This role offers hands-on impact in a general, fast-paced study environment.
Compensaciones / Beneficios • Support GSD, GSAD, and GSMs with delegated clinical study execution activities • Initiate and maintain eTMF setup, and ensure compliance with ICH/GCP and AZ SOPs • Collaborate with Site Management u0026 Monitoring, internal stakeholders,
and external vendors to collect regulatory and essential study documentation • Contribute to electronic submissions by creating/managing clinical and regulatory documents to standards • Plan and coordinate CSR administrative appendices • Set up and maintain study documentation with template/version compliance • Manage information in AstraZeneca tracking/communication tools to assist study teams • Support setup, maintenance, and close-out of Clinical Trial Transparency (CTT) in PharmaCM • Monitor study budgets/payments in relevant systems • Contribute to application, coordination, supply, and tracking of study materials and equipment
Responsabilidades • Education in medical or biological sciences or related clinical research field (preferred) • Proven organizational and analytical skills • Previous administrative training or experience • Strong computer proficiency for day-to-day activities • Ability to understand clinical study processes and ICH/GCP guidelines • Excellent verbal and written English communication • Ability to work independently and in a team • Ability to prepare presentation materials
Requisitos principales •
📌 Global Study Associate, Late Development Oncology (Barcelona)
🏢 AstraZeneca
📍 Barcelona