Study Start-Up Manager, Oncology - 12 Month Contract/Secondment
Study Start-Up Manager, Oncology
Hybrid Work- on average 3 days/week from our Mississauga office
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.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
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.
They are also 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.
Key Tasks
Preparation & Submission of the EC submission file following clinical trial application files dispatch. Primary reviewer of site level Informed Consent Forms. Follow up on intermediate letters, questions and answers, authorization.
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.
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 SM&M.
Share information (metrics) on study site progress towards activation within local Study Delivery Team and SM&M leadership as required.
Update Veeva Clinical Vault (VCV) and other systems with data from sites.
Contribute to the production of study start up documents, ensuring template and version compliance.
Essentials for the role:
University degree (or equivalent), preferably in medical or biological sciences or field associated with clinical research
Minimum 3 years experience within the pharmaceutical industry supporting clinical operations.
Oncology site management experience an asset.
Project management, organizational and analytical skills
Knowledge of clinical development/ drug development process across various phases and therapy areas as well as relevant knowledge of international guidelines ICG-GCP
Computer proficiency
Excellent knowledge of spoken and written English. French language is an asset
Cell therapy experience is preferred
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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.
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.
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