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 Mississauga 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.

ACCOUNTABILITIES:

• Provide operational expertise to the study team.
• Lead the development and updates of study documents, ensuring template and version compliance.
• Prepare country-specific agreements, confidentiality agreements, clinical trial applications, and other applicable country documents.
• Foster team culture and promote team spirit within the GSMs and GSAs assigned to the study team.
• Mentor and guide the operations team to ensure effective collaboration and communication with the study team.
• Manage the set-up of third-party vendors, assess initial statements of work and budgets, and handle the change order process.
• Provide input to data management documents and interface with data management representatives and sites to facilitate study data delivery.
• Initiate contract/budget requests, track ongoing status, facilitate generation of purchase orders, review vendor invoices, and assist in tracking spend against approved budget.
• Ensure the supply of investigational products and study materials by liaising with Drug Supply or external service providers as appropriate.
• Oversee third-party vendors, global/local internal staff, and investigator sites to support effective delivery of a study and its regulatory documents from protocol development through to the Clinical Study Report.
• Provide oversight of 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 that 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 implementing audits and regulatory inspections.
• Identify areas of best practice/process improvements and share knowledge across the group.
• Contribute to the review of new/amended/unique SOPs and guidance documents.

ESSENTIAL SKILLS/EXPERIENCE:

• 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 a minimum of 5 years clinical trial experience, including at least 2 years in global study management
• Experience working with and delivering through strategic partners and 3rd party vendors
• Excellent knowledge of ICH-GCP principles
• Team-oriented
• Ability to lead, coordinate, and prioritize 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 SKILLS/EXPERIENCE:

• Early phase oncology clinical trial experience

Are you ready to lead the operational activities that support and enable the delivery of clinical studies? As a Senior Global Study Manager, you will ensure quality and compliance in our clinical programs. Flexibility is key as accountabilities will vary depending on the nature of each clinical program.