Job Description

This is a 12 month contract:
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 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 and BlueSky Hub in downtown Toronto are 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\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Description: You will lead and coordinate to the global clinical studies to ensure quality, consistency, and integration of Canadian study data and progress operational deliverables to time, cost and quality from study start through study close-out activities. You work with internal and external partners, on studies across various phases of drug development and various therapy areas. Accountabilities/Responsibilities:

• Plan and deliver local commitment of global clinical studies to the agreed time, budget and scope
• Coordinate and lead local study team meetings
• Develop or provide study related input to local and global study documents including clinical study protocols, consent forms, source data verification plans, data management plans, risk management plans and recruitment action plans
• Develop, coordinate and deliver study training for the local study team members, site monitors and possibly investigators
• Lead site start-up activities including ethics submission, informed consent review, development and finalization of clinical study agreements, site specific budget negotiations, site system set-ups, site vendor set-up, recruitment expectations, and follow-up and maintenance of all study activities
• Develop and maintain study budget, study timelines, and study resources and update tracking systems appropriately
• Coordinate data management activities, such as query resolution, SDV and timelines for final data entry
• Plan and lead activities associated with audits in liaison with clinical quality assurance.

Minimum Requirements \xe2\x80\x93 Education and Experience

• Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields
• Experience working on clinical studies
• At least 5 years experience from within the pharmaceutical industry or similar organization or academic experience.
• Extensive knowledge of clinical operations, project management tools and processes
• Proven organizational and analytical skills
• Vaccine and Immunology experience is an asset

Skills and Capabilities

• Excellent interpersonal skills and demonstrated ability to work and lead cross-functional teams with internal and external partners
• Demonstrated Project Management skills
• Displays excellent organization and time management skills, high level attention to detail, and ability to work in a high volume environment with shifting priorities
• High level of understanding of clinical data flow
• Excellent verbal and written communication and presentation skills
• Demonstrates sound knowledge of GCP, procedural documents, as they pertain to study delivery systems and processes
• Proactively identifies risks, issues and possible solutions
• Demonstrates high standards and uses tactful persuasion to obtain desired outcomes while maintaining effective, positive, organizational relationships
• Develops core knowledge of therapy areas for responsible studies
• Demonstrates professionalism and mutual respect
• Willingness to travel both domestically and internationally.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 9 years
• Learn about our culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ, apply today! AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca\xe2\x80\x99s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process. 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.