Global Study Associate (Oncology) | 12-Month Term

AstraZeneca; Województwo mazowieckie; On-site; PLN 120,000 - 170,000; Full time

Job summary

AstraZeneca invites applications for a 12-month fixed term role supporting late development oncology studies from CSP development to CSR. The role involves coordinating eTMF setup, regulatory document collection, and interaction with site management, vendors, and internal teams.

The candidate should have education in medical/biological sciences, strong organization and English communication, and the ability to work independently and with a team.

Qualifications

• Essential: Education in medical or biological sciences preferred.
• Essential: Proven organizational and analytical skills.
• Essential: Previous administrative training/experience.
• Essential: Computer proficiency in day-to-day tasks.
• Essential: Working knowledge of the Clinical Study Process and ICH/GCP.
• Essential: Excellent verbal and written communication in English.
• Essential: Ability to work independently and in a team.
• Essential: Ability to prepare presentation materials.

Responsibilities

• Support GSD/GSAD and GSMs by completing delegated study work.
• Set up and maintain the electronic Trial Master File (eTMF) to ICH/GCP and AZ SOPs.
• Collaborate with Site Management, internal staff, and external vendors for regulatory documents.
• Contribute to clinical-regulatory documents and CSR appendices.
• Produce and maintain study materials with templates and version control.
• Maintain AstraZeneca tracking tools and assist teams in their use.
• Support CTTA activity in PharmaCM and coordinate with stakeholders.
• Track study budgets/payments in relevant systems.
• Coordinate administrative tasks and logistics for audits and inspections.
• Prepare and distribute material for meetings and newsletters.

Skills

Organizational skills

Analytical skills

English communication

Independent working

Team collaboration

Presentation skills

Time management

Education

Bachelor level education in medical/biological sciences

Job description

AstraZeneca invites applications for a 12-month fixed term role supporting late development oncology studies from CSP development to CSR. The role involves coordinating eTMF setup, regulatory document collection, and interaction with site management, vendors, and internal teams.

The candidate should have education in medical/biological sciences, strong organization and English communication, and the ability to work independently and with a team.