15 oct
|
AstraZeneca
|
Barcelona
15 oct
AstraZeneca
Barcelona
Overview As General 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 global, fast-paced study environment.
Responsabilidades
- 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 & 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 Astra Zeneca 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 Requisitos principales
- 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
- Excellent communication
- Teamwork and collaboration
- Analytical thinking
- eTMF setup and management
- ICH/GCP knowledge
- SOPs familiarity
📌 Global Study Associate, Late Development Oncology (Barcelona)
🏢 AstraZeneca
📍 Barcelona