Global Clinical Study Coordinator

AstraZeneca plc; Spain; On-site; EUR 55,000 - 75,000; Full time

Job summary

AstraZeneca plc is seeking a Global Study Associate to support the delivery of global clinical studies within BioPharmaceuticals Clinical Operations. The role focuses on ICH-GCP compliant study execution, eTMF setup, and coordination with GSD, GSAD, and GSM to ensure quality and timelines.

Responsibilities include regulatory document management, collaboration with internal and external stakeholders, and application support across information management systems to enable efficient study conduct

Qualifications

• Education in medical or biological sciences or related field
• Proven organizational and analytical skills
• Previous administrative training/experience
• English verbal and written communication
• Ability to work independently and in a team

Responsibilities

• Set up and maintain the electronic Trial Master File (eTMF) per ICH/GCP and AZ SOPs.
• Coordinate regulatory documents and support regulatory submissions.
• Support budget tracking and vendor oversight for non-critical path activities.
• Prepare study materials and participate in team meetings.

Skills

Study administration

ICH/GCP knowledge

Regulatory document management

English communication

Team collaboration

Independent work

Education

Bachelor level education in medical/biological sciences

Experience in clinical study lifecycle

Job description

AstraZeneca plc is seeking a Global Study Associate to support the delivery of global clinical studies within BioPharmaceuticals Clinical Operations. The role focuses on ICH-GCP compliant study execution, eTMF setup, and coordination with GSD, GSAD, and GSM to ensure quality and timelines.

Responsibilities include regulatory document management, collaboration with internal and external stakeholders, and application support across information management systems to enable efficient study conduct