Global Study Manager

AstraZeneca • Mississauga, ON

2d • Hybrid

About The Position

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 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’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

You are a member of the extended global study team supporting delivery of clinical studies to time, cost and quality from Clinical Study Protocol (CSP) development through to study archiving. You will work cross-functionally building partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery. You will maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other outside service providers to ensure an efficient study delivery. You will lead and/or participate in the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc.) and external service provider related documents (e.g. specifications). You will support the Global Study Associate Director (GSAD) in project management as per agreed delegation. You ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers. You help support the GSAD with budget management, such as external service provider invoice reconciliation. You make sure studies are inspection-ready at all times according to ICH-GCP, AZ SOP and relevant policies/guidelines. You will ensure that all study documents in scope of Global Study Manager's (GSM) responsibilities are completed and verified for quality in the Trial Master File. You will assist with the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting). You will monitor study conduct and progress, identifying and resolving risks and issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the GSAD. You will contribute to ad hoc team productivity and efficiency by providing direction and facilitating positive team dynamics. You will have the opportunity to provide input into non-drug project work including training activities and the development of procedures as needed. You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and SOPs.

Requirements

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
• Minimum 3 years experience within the pharmaceutical industry supporting clinical operations
• Haematology/Oncology experience
• Shown 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

Nice To Haves

• Global clinical research experience in managing multiple countries
• Vendor management
• Sponsor experience or having worked in a Functional Service Provider (FSP) model previously for another sponsor

Responsibilities

• Support delivery of clinical studies to time, cost and quality from Clinical Study Protocol (CSP) development through to study archiving.
• Work cross-functionally building partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery.
• Maintain and facilitate interactions with internal functions (Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance) and external functions (CROs and other outside service providers) to ensure efficient study delivery.
• Lead and/or participate in the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc.) and external service provider related documents (e.g. specifications).
• Support the Global Study Associate Director (GSAD) in project management as per agreed delegation.
• Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers.
• Support the GSAD with budget management, such as external service provider invoice reconciliation.
• Ensure studies are inspection-ready at all times according to ICH-GCP, AZ SOP and relevant policies/guidelines.
• Ensure that all study documents in scope of Global Study Manager's (GSM) responsibilities are completed and verified for quality in the Trial Master File.
• Assist with the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting).
• Monitor study conduct and progress, identifying and resolving risks and issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the GSAD.
• Contribute to ad hoc team productivity and efficiency by providing direction and facilitating positive team dynamics.
• Provide input into non-drug project work including training activities and the development of procedures as needed.
• Responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and SOPs.

Benefits

• Competitive Flex Benefits & Retirement Savings Program
• 4 weeks’ paid vacation
• Annual Personal Days
• Annual Variable Pay Bonus/Short Term Incentive opportunity
• Eligibility to participate in our equity-based long-term incentive program (if applicable to role)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level