Global Study Associate - 12 Month Contract at AstraZeneca

Mississauga, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Organizational Skills, Analytical Skills, Administrative Experience, Computer Proficiency, Clinical Study Process Knowledge, Communication Skills, Teamwork, Presentation Skills, Professionalism, Time Management, Attention to Detail, Multi-tasking, Study Administration Procedures, Process Improvement, Regulatory Compliance, Budget Tracking

Industry

Pharmaceutical Manufacturing

Description

Introduction to role Are you ready to make a significant impact in the world of clinical research? As a Global Study Associate (GSA), you'll be an integral part of the extended global study team, driving the delivery of clinical studies within Late Development Oncology. From the development of Clinical Study Protocols to study archiving, you'll support the Global Study Director and Managers in executing clinical studies with precision and efficiency. Your role will involve navigating AstraZeneca's Project Management Framework, adhering to clinical trial regulations, and embodying our values and behaviors. Are you up for the challenge? Note: This is a 12 Month Contract Accountabilities Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) by completing delegated study work. 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 Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs. Interact/collaborate with Site Management & Monitoring, other internal staff and external vendors in collection of regulatory and other essential documents. Contribute to electronic applications/submissions by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR. 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 GSD/GSAD with tracking, reconciliation and follow-up of the study budget/payments in relevant systems. Contribute to application, coordination, supply and tracking of study materials and equipment. Contribute to collection of study supplies, if required, at the study close-out. 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. Prepares, 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 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 Great People want to Work with us! Find out why: GTAA Top Employer Award for 10 years Top 100 Employers Award Canada’s Most Admired Corporate Culture Learn more about working with us in Canada View our YouTube channel Are you interested in working at AZ, apply today! AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com. Date Posted 12-Dec-2025 Closing Date 18-Dec-2025 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 authorization and employment eligibility verification requirements.

Responsibilities

The Global Study Associate will support the Global Study Director and Managers in executing clinical studies, including managing the electronic Trial Master File and coordinating with various stakeholders. The role also involves preparing study documents and ensuring compliance with clinical trial regulations.