Global Study Associate: eTMF Lead & Study Admin

AstraZeneca; Warszawa; On-site; PLN 120,000 - 180,000; Full time

Job summary

AstraZeneca is seeking a Global Study Associate to support delivery of global clinical studies from setup through close-out. You will assist with eTMF set-up, maintenance, and regulatory document management in ANGEL and other AZ systems.

The role requires strong organizational, analytical, and communication skills, with experience in study administration and knowledge of ICH-GCP guidelines. Collaboration with internal teams and external stakeholders is essential.

Qualifications

• Essential: Education in medical or biological sciences or related clinical research field.
• Essential: Proven organizational and analytical skills.
• Essential: Administrative training/experience.
• Essential: Computer proficiency for daily tasks.
• Essential: Understanding of ICH-GCP and AZ SOPs.
• Essential: Excellent English communication and ability to work independently or in a team.
• Desirable: Bachelor level education or higher; experience on a study level.
• Desirable: Experience across the clinical study lifecycle.

Responsibilities

• Support study leads by completing delegated study tasks across multiple studies.
• Initiate and lead eTMF set-up; maintain and close eTMF per ICH-GCP and AZ SOPs.

Skills

Proven organizational skills

Strong English communication

Analytical skills

Team collaboration

Study administration

Education

Bachelor's degree in medical/biological sciences

Tools

eTMF system

ANGEL

PharmaCM

Clinical study process

Job description

AstraZeneca is seeking a Global Study Associate to support delivery of global clinical studies from setup through close-out. You will assist with eTMF set-up, maintenance, and regulatory document management in ANGEL and other AZ systems.

The role requires strong organizational, analytical, and communication skills, with experience in study administration and knowledge of ICH-GCP guidelines. Collaboration with internal teams and external stakeholders is essential.