Global Study Coordinator, Clinical Trials (Oncology)

AstraZeneca; Barcelona; On-site; EUR 42,000 - 62,000; Full time

Job summary

AstraZeneca is seeking a Global Study Associate to support the delivery of clinical studies in Late Development Oncology (LDO) to time, cost, and quality standards. The role covers study setup through CSR development and archiving, aligning with ICH/GCP, AZ SOPs and internal policies.

Working with the GSD, GSAD and GSMs, the GSA helps across delegated activities of study execution, contributing to regulatory filings and study documentation, eTMF setup, and budget tracking.

Qualifications

• Education in medical or biological sciences preferred.
• Proven organisational and analytical skills.
• Previous administrative training or experience.
• Strong computer proficiency for day-to-day activities.
• Excellent verbal and written communication in English.

Responsibilities

• Support the GSD, GSAD, and GSMs by completing delegated activities related to clinical study execution.
• Initiate and lead the set-up of the electronic Trial Master File (eTMF), and maintain/close it per ICH/GCP and AZ SOPs.
• Collaborate with Site Management & Monitoring teams and external vendors to collect regulatory and essential study documentation.
• Contribute to electronic applications and submissions by creating and managing clinical/regulatory documents.
• Plan and coordinate administrative appendices for the CSR.
• Maintain study documentation with templates and version control.
• Set up and maintain AstraZeneca tracking/communication tools for the study team.
• Support Clinical Trial Transparency activities in PharmaCM and ensure regulatory compliance.
• Assist GSD/GSAD with tracking, reconciliation, and follow-up of study budgets and payments.
• Contribute to material and equipment coordination for the study.

Skills

Organisational skills

Analytical skills

Administrative experience

Computer proficiency

English communication

Teamwork

Presentation skills

Education

Medical/biological sciences education

Job description

AstraZeneca is seeking a Global Study Associate to support the delivery of clinical studies in Late Development Oncology (LDO) to time, cost, and quality standards. The role covers study setup through CSR development and archiving, aligning with ICH/GCP, AZ SOPs and internal policies.

Working with the GSD, GSAD and GSMs, the GSA helps across delegated activities of study execution, contributing to regulatory filings and study documentation, eTMF setup, and budget tracking.