Global Study Associate, Oncology (12 Month Contract)
Global Study Associate, Oncology (12 Month Contract)
Do you have expertise in and passion for delivering clinical studies? Would you like to apply your expertise to help patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
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.
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 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 contribute to the application, coordination, supply and tracking of study materials and equipment
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
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.
Great People want to Work with us! Find out why:
GTAA Top Employer Award for 7 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada
Browse AstraZeneca's YouTube channel to find out more about us: https://www.youtube.com/user/astrazeneca
Are you interested in working at AZ, apply today!
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 authorisation and employment eligibility verification requirements.