Study Start-Up Manager, Oncology

Remote Work within Canada

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

The Oncology Study Start-Up Manager (Onc SSU Manager) has local responsibility for the delivery of site start up activities for assigned studies and are active participants in the study team(s). The Onc SSU Manager works in close collaboration with Monitors, Support Services, Research sites, Local Health Authorities and Ethics Committees and the Local Study Delivery Team to ensure that quality and quantity of site activation deliverables are achieved in a timely and efficient manner.

The Onc SSU Manager is responsible for ensuring that all requirements for site activation are in place for the agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. Deliver according to the commitment in the individual trials and local site activation process.

An Onc SSU Manager with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Associate Director as appropriate locally.

Responsibilities:

• Drive delivery of regulatory documents at the sites. Proactively ensure submission and activation against effective planned timelines defined with the LST, and identify delays in start-up activities and the risks to the activation plan.
• 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).
• Activate study sites in compliance with AZ Procedural Documents.
• 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.
• Follow up on intermediate letters, questions and answers, authorization
• Primary reviewer of site level Informed Consent Forms, as locally appropriate
• Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents.
• Actively participate in local Study Delivery Team meetings and work cross functionally with Contracts, Feasibility and Study Support Services in SM&M.
• 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.
• Update Veeva Clinical Vault (VCV) and other systems with data from centres as per required per SAT process, as locally appropriate.
• 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).
• 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.
• Share information (metrics) on study site progress towards activation within local Study Delivery Team and SM&M leadership as required.
• Assist in coordination and administration of clinical studies from start-up through site activation.
• Preparation & Submission of the EC submission file following clinical trial application files dispatch & amendement dispatch
• Ensure that all start up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
• Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
• Contribute to the production of study start up documents, ensuring template and version compliance.
• Preparation & Submission of the local RA submission file following clinical trial application files dispatch & amendments dispatch
• Filing of documents on AZ filing system, with support of CSA
• Ensure timely delivery of proper documents for support of study team submission to Regulatory Authorities.

Additional Responsibilities:

• Contribute to process improvements, knowledge transfer and best practice sharing.
• Proactively share applicable information that may be relevant to other functions

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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 [email protected].