Job Description

Are you ready to play a pivotal role in the site activation process for clinical studies? Specialist in the Site Activation Team (SAT), coordinating the timely start of site activities. Collaborating closely with MoniWork closely with Research sites, Support Services, and Local Study Delivery Team to ensure timely site activation. in aligning with AZ Procedural Documents, international guidelines like ICH and GCP, and local regulations. With experience, you may also take on additional responsibilities as a Site Activation Team Leader (SATL). Are you prepared to make a difference?

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

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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.