AstraZeneca is a global, science-led biopharmaceutical company focused on discovering, developing, and commercializing prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals. With a strong commitment to innovation, AstraZeneca is at the forefront of medical advancements, delivering life-changing treatments to patients worldwide.
The company fosters a culture of collaboration, diversity, and continuous learning, empowering employees to push boundaries in drug development. AstraZeneca’s Development Operations Business Enablement function plays a crucial role in ensuring seamless clinical study execution, making it an exciting workplace for professionals in clinical research.
Job Description
As a Central Global Study Associate (CGSA), you will be part of a dynamic team supporting clinical study activities across multiple therapeutic areas and phases. This role involves administrative, operational, and coordination tasks to ensure efficient clinical trial execution while maintaining compliance with regulatory standards.
Key Responsibilities:
✔ Execute tasks requested by the Global Study team via a central ticketing system (e.g., TMF QC, Investigator Brochure distribution).
✔ Manage Trial Master File (TMF) setup, maintenance, closeout, and archiving, ensuring compliance with quality checks.
✔ Collaborate with global study teams to assist in study initiation, conduct, and closeout activities.
✔ Maintain tracking systems, generate study reports, and distribute materials to stakeholders.
✔ Prepare and review study documents, ensuring adherence to templates and version control.
✔ Serve as a Subject Matter Expert (SME) for CGSA-related processes and tools.
✔ Support training for study teams and assist in audits/inspections.
Essential Skills & Qualifications:
✅ Bachelor’s degree or equivalent experience in life sciences or related fields.
✅ 1-3 years of experience in clinical study administration/operations.
✅ Strong understanding of drug development and clinical trial processes.
✅ Proficiency in Microsoft Office, eTMF, and Veeva Systems.
✅ Excellent organizational, communication (English), and time-management skills.
✅ Ability to work in a fast-paced, collaborative environment.
Desirable Skills:
✔ Knowledge of ICH-GCP guidelines.
✔ Strong problem-solving and relationship-building skills.
✔ Experience in regulatory document management.
Why Join AstraZeneca?
🔹 Innovative Environment: Work on cutting-edge clinical trials with a global impact.
🔹 Career Growth: Tailored development programs to enhance your skills.
🔹 Hybrid Work Model: Minimum 3 days/week in-office with flexibility.
🔹 Inclusive Culture: Commitment to diversity, equity, and belonging.
How to Apply
📅 Closing Date: June 16, 2025
