Global Study Associate
At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.
Our purpose is ambitious and so is our approach. Becoming a more agile and creative company means building a dynamic, inspiring culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We are courageous, taking smart risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver life-changing medicines.
Position Title: Global Study Associate
Position Type: Full-time, Contract
Career Level: C
Location: Mississauga, Ontario
You are a member of extended global study team supporting delivery of clinical studies to time, cost and quality, from Clinical Study Protocol (CSP) development through to study archiving. The GSA supports Global Study Leader (GSL) and Global Study Associate Managers (GSAM) in delegated aspects of clinical study.
- 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 will be responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and SOPs
- 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
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 6 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada
- Best Workplace Culture Award at the 2018 Canadian HR Awards:https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
- Learn more about our culture:https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G
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.