Accountabilities:
- Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents.
- Assist in coordination and administration of clinical studies from start-up through site activation.
- Actively participate in local Study Delivery Team meetings and work cross-functionally with Contracts, Feasibility, and Study Support Services in US SM&M.
- Activate study sites in compliance with AZ Procedural Documents.
- Share information (metrics) on study site progress towards activation within local Study Delivery Team and US SM&M leadership as required.
- Drive delivery of regulatory documents at the sites. Proactively identify delays in start-up activities and the risks to the activation plan.
- Primary reviewer of site level Informed Consent Forms.
- Update Veeva Clinical Vault (VCV) and other systems with data from centres as required per SAT process.
- Ensure regulatory binders and study supplies are provided for study site start-up and/or delivered as per SAT process and agreement with Local Study Delivery Team.
- Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
- Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
- Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva).
- Ensure timely delivery of proper documents for support of study team submission to Regulatory Authorities.
- Ensure that all start-up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
- Contribute to the production of study start-up documents, ensuring template and version compliance.
- Create and/or import clinical-regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL.
- Set-up, populate, and accurately maintain information in AstraZeneca tracking and communication tools (e.g., Veeva, MS Teams, Box etc.) and support others in the usage of these systems.
Additional Responsibilities:
- Contribute to process improvements, knowledge transfer, and sharing guidelines.
- Actively share applicable information that may be relevant to other functions.
Essential Skills/Experience:
- Bachelor’s degree or equivalent experience in a related field
- Experience of Study Management within a pharmaceutical or clinical background
- Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management
Desirable Skills/Experience:
- Cell therapy
- Advanced degree within the field
- Professional certification
- Understanding of multiple aspects within Study Management
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
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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
04-Nov-2025
Closing Date
17-Nov-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.