Global Study Associate

**Global Study Associate, Oncology**

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.

**Our Oncology Research and Development Team**:
Our pioneering approach is identifying and treating patients earlier, focusing on early stage cancer trials and listening and evolving based on their needs. As a team we are deeply committed to transforming the lives of patients living with cancer - with the ultimate aim of eliminating cancer as a cause of death.

**What you’ll do**:

- You will support Global Study Leaders (GSL) and Global Study Associate Managers (GSAMs) by completing delegated study work
- You initiate the set-up, maintain and close the electronic Trial Master File (eTMF) to ensure compliance to International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs
- You will partner with internal functions and external vendors in collection of regulatory and other essential documents
- You will initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements
- You will set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint, BOX if used, MS teams and study team shared mailbox) and support team members in the usage of these tools
- You will lead administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs
- You will oversee and contribute to the preparation of internal and external meetings e.g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. You will liaise with internal and external participants and/or vendors
- You will build and prepare presentation material for meetings, newsletters and web-sites
- You will have the opportunity to provide input into non-drug project work including training activities, and development of procedures as needed
- You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and SOPs

**Essentials for the role**:

- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research preferred;
- Meaningful clinical experience at administrative level supporting the delivery of clinical trials
- Validated 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 clear comprehension 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 integrity and mutual respect
- Desire and capability to train others on study administration procedures
- Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities

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