Global Study Operations Specialist

AstraZeneca; Barcelona; On-site; EUR 48,000 - 72,000; Full time

Job summary

AstraZeneca is seeking a Global Study Associate to support the global study team in delivering clinical studies on time, within budget and to quality. You will assist with study setup, maintenance, and close‑out, coordinate regulatory documents, eTMF activities and cross‑functional tasks in compliance with ICH‑GCP and AZ SOPs.

Ideal candidates will have medical or biological science education, strong organizational skills, fluency in English, and the ability to train others and work

Qualifications

• Education in medical or biological sciences or discipline associated with clinical research preferred
• Proven organizational and analytical skills
• Previous administrative training/experience
• Computer proficiency in day‑to‑day tasks
• Develop working knowledge of the Clinical Study Process and ICH/GCP guidelines
• Excellent verbal and written communication in English
• Demonstrate ability to work independently, as well as in a team environment
• Ability to prepare presentation materials
• Demonstrate professionalism and mutual respect
• Willingness and ability to train others on study administration procedures
• Display excellent organization and time management skills, attention to detail, and ability to multi‑task in a high‑volume environment with shifting priorities

Responsibilities

• Support GS(A)D and GSMs by completing delegated study work.
• Initiate and lead the set-up of the electronic Trial Master File (eTMF) and maintain/close it to ICH/GCP and AZ SOPs.
• Provide oversight for non‑complex, non‑critical path vendors.
• Interact with internal staff and external stakeholders to collect regulatory documents.
• Contribute to regulatory submissions in information management systems and prepare CSR appendices.
• Create and maintain study documents with template and version control.
• Set up and maintain AstraZeneca tracking/communication tools.
• Support Clinical Trial Transparency activity in PharmaCM.
• Assist GS(A)D with tracking and payments in relevant systems.
• Coordinate study materials, equipment, and study close‑out logistics.
• Coordinate internal/external meetings and prepare materials for distribution.

Job description

AstraZeneca is seeking a Global Study Associate to support the global study team in delivering clinical studies on time, within budget and to quality. You will assist with study setup, maintenance, and close‑out, coordinate regulatory documents, eTMF activities and cross‑functional tasks in compliance with ICH‑GCP and AZ SOPs.

Ideal candidates will have medical or biological science education, strong organizational skills, fluency in English, and the ability to train others and work