Global Study Associate, Haematology

2 weeks ago

Mississauga, Canada AstraZeneca Full time

**Global Study Associate, Haematology (12 Month Contract)**

**About AstraZeneca**:
AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

**AstraZeneca Canada**

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others.

Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond.

**Our Haematology** **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

**Why AstraZeneca?**

This is the place to make a meaningful impact - on patients’ lives and your personal growth. It’s both rewarding and inspiring, and it’s what keeps us motivated every day.

**Grea

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