The Global Study Associate (GSA) is a member of the extended Global Study Team, supporting the delivery of clinical studies within Late Development Oncology (LDO) to time, cost, and quality standards.

The GSA supports clinical studies throughout their lifecycle, from Clinical Study Protocol (CSP) development and study set-up through maintenance, close-out, Clinical Study Report (CSR) development, and study archiving.

Working closely with the Global Study Director (GSD), Global Study Associate Director (GSAD), and Global Study Managers (GSMs), the GSA provides support across delegated aspects of clinical study execution, ensuring alignment with the AZ Project Management Framework, current clinical trial regulations such as ICH/GCP, AstraZeneca Standard Operating Procedures (SOPs), internal policies, guidelines, best practices, and AZ values and behaviours.

Key Responsibilities:

• Support the GSD, GSAD, and GSMs by completing delegated activities related to clinical study execution.
• Initiate and lead the set-up of the electronic Trial Master File (eTMF), as well as maintain and close the eTMF, ensuring compliance with ICH/GCP requirements and AZ SOPs.
• Collaborate with Site Management & Monitoring teams, other internal stakeholders, and external vendors to collect regulatory and other essential study documentation.
• Contribute to electronic applications and submissions by creating and managing clinical and regulatory documents according to required technical standards, supporting effective publishing and delivery to regulatory authorities.
• Proactively plan and coordinate the administrative appendices required for the Clinical Study Report (CSR).
• Initiate and maintain study documentation, ensuring appropriate template and version compliance according to study-specific requirements.
• Set up, populate, and accurately maintain information within AstraZeneca tracking and communication tools, while supporting study team members in their use.
• Support the set-up, maintenance, and close-out of Clinical Trial Transparency (CTT) activities in PharmaCM, coordinating with relevant stakeholders to ensure AstraZeneca compliance and meet regulatory authority requirements.
• Support the GSD/GSAD with the tracking, reconciliation, and follow-up of study budgets and payments in relevant systems.
• Contribute to the application, coordination, supply, and tracking of study materials and equipment.

Education, Qualifications, Skills & Experience:

• Education in medical or biological sciences, or another discipline related to clinical research, is preferred.
• Proven organisational and analytical skills.
• Previous administrative training or experience.
• Strong computer proficiency for day-to-day activities.
• Ability to develop a working knowledge of the clinical study process and related procedures, including an understanding of ICH/GCP guidelines.
• Excellent verbal and written communication skills in English.
• Ability to work effectively both independently and within a team environment.
• Ability to prepare presentation materials.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.