Global Study Associate

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**Introduction to role**:
The Global Study Associate (GSA) is a vital member of the extended global study team, supporting the delivery of clinical studies within BioPharmaceuticals Clinical Operations. The GSA ensures that clinical studies are driven efficiently from set-up through maintenance, close-out, and archiving. Working closely with the Global Study Director (GSD), Global Study Associate Director (GSAD), and/or Global Study Manager (GSM), the GSA coordinates activities to maintain quality and consistency. This role involves administrative support, system management, and adherence to clinical trial regulations, AstraZeneca Standard Operating Procedures (SOPs), policies, best practices, and values.

**Accountabilities**:
Support GS(A)D and GSMs by completing delegated study work. May work across many different studies and delivery models concurrently.
- Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.
- Interact/collaborate with internal staff and external stakeholders in collection of regulatory and other essential documents.
- Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements.
- Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools and support team members in the usage of these tools.
- Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs.
- Support the GS(A)D with tracking, reconciliation and follow-up of the study budget/payments in relevant systems.
- Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs.
- Lead the practical arrangements, coordination and contribute to the preparation of internal and external meetings e.g., study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. Liaise with internal and external participants and/or vendors.
- Prepare, contribute and distribute presentation material for meetings, newsletters and websites.
- Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

**Essential Skills/Experience**:

- 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 an understanding of the range of working procedures relating to it, together with an understanding of the 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
- Bachelor level education (or higher)
- Proven study admin/assistant or relevant experience on a study level
- Experience in clinical study lifecycle
- Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high
- volume environment with shifting priorities

**Desirable Skills/Experience**:

- Bachelor level education (or higher)
- Proven study admin/assistant or relevant experience on a study level
- Experience in clinical study lifecycle

LI-Hybrid