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 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 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are 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, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.
