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.

The Senior Global Study Manager is responsible for leading the operational activities to support and enable the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.

Accountabilities:

• Provides operational expertise to the study team.
• Lead the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
• Create team culture and promotes team spirit within the GSMs and GSAs assigned to the study team.
• Provide mentoring and guidance to the operations team ensuring effective collaboration and communication with the study team.
• Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specification), and interface with data management representatives and sites to facilitate the delivery of study data.
• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
• Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
• Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
• Oversee the clinical trial insurance process; track approvals, revisions and renewals of certificates.
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
• Drive risk management and quality efforts to ensure study compliance.
• Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
• Prepare presentation material for meetings, newsletters and websites.
• Direct the study team in the implementation of audits and regulatory inspections.
• Identify areas of best practice / process improvements and knowledge share across the group.
• Contribute to review of new/amended/unique SOPs and guidance documents.

Essential:

• University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
• Deep understanding of the drug development process with minimum of 5 years clinical trial experience, of which at least 2 years are in global study management
• United States only: Bachelor's Degree and 5+ years of experience, Associate's degree plus 9+ years of experience or High School plus 13+ years of experience, of which at least 2 years are in global study management
• Experience of working with and delivering through strategic partners and 3rd party vendors
• Excellent knowledge of ICH-GCP principles
• Team orientated
• Ability to lead, coordinate and prioritise multiple tasks and deliverables
• Proactive approach
• High degree of flexibility
• Demonstrated verbal and written communication skills
• Good negotiation and collaboration skills
• Demonstrated interpersonal and problem-solving skills
• Ability to manage change and actively seek and champion more efficient and effective ways of working
• Ability to coach & act as a buddy for more junior colleagues
• Some travel may be required

Desirable:

• Early phase oncology clinical trial experience