Global Study Manager

AstraZeneca • Mississauga, ON

3d • CA$109,149 - CA$143,258 • Hybrid

About The Position

As a Global Study Manager, you will provide end-to-end oversight of assigned studies, partnering closely with internal experts and external service providers to turn robust plans into reliable execution. You will be central to how we deliver, using clear governance, smart risk management, and crisp communication to keep studies inspection ready and moving with pace. You will join a driven, collaborative team that embraces experimentation and data-enabled decision-making. Here, your judgment and leadership will shape study operations from documents and meetings to CRO performance and supply continuity—ultimately accelerating therapies that make a real difference for patients.

Requirements

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• Experience providing oversight to ensure study delivery in partnership with internal teams, clinical experts, and external service providers.
• Demonstrated ability to lead and contribute to the preparation of study documents, including Informed Consent Forms, master Clinical Study Agreements, vendor specifications, study-specific procedures, descriptions, and presentations.
• Experience maintaining and facilitating interactions with CROs and other external service providers to deliver to time, cost, and quality objectives.
• Experience planning and conducting internal and external meetings, such as Investigators’ and Monitors’ meetings.
• Experience liaising with Clinical Supply Chain or external providers to ensure supply of investigational product and study materials.
• Proven ability to proactively identify risks and issues and to develop mitigation and/or action plans.
• Experience ensuring that study documents within scope are complete and verified for quality in the Trial Master File.
• Experience supporting GSD and/or GSAD with budget management, including external service provider invoice reconciliation.
• Consistent adherence to global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and ICH/GCP to maintain inspection readiness.
• Experience supporting GSD and/or GSAD with overall project management as delegated.
• For outsourced studies, experience supporting management of the CRO Project Manager to ensure delivery according to agreed timelines, budget, and quality standards, while maintaining and documenting appropriate oversight throughout the study lifecycle, in accordance with relevant SOPs and guidelines (e.g., description of services and transfer of obligations).
• Experience taking on assignments in process improvements and/or leading improvement projects.

Nice To Haves

• Experience delivering global, multicenter studies across multiple phases or therapeutic areas.
• Expertise with eTMF systems, study start-up workflows, and site activation optimization.
• Strong vendor governance capabilities, including performance metrics, risk-based oversight, and contract change control.
• Exposure to inspection/audit preparation and response, with a record of successful outcomes.
• Proficiency with budget tracking tools and financial reconciliation for outsourced activities.
• Formal project management training or certification (e.g., PMP) and/or Lean or Six Sigma experience.
• Ability to translate complex operational issues into clear, actionable plans for cross-functional teams.
• Strong communication skills that build trust across geographies and cultures, with a focus on decision-speed and clarity.

Responsibilities

• Own day-to-day oversight with internal teams, clinical experts, and external providers to deliver studies to agreed timelines, budget, and quality—linking operational decisions to patient impact and portfolio value.
• Lead and contribute to the preparation of key documents, including Informed Consent Forms, master Clinical Study Agreements, vendor specifications, study procedures, and presentations—ensuring clarity, compliance, and reuse across programs.
• Maintain strong, structured interactions with CROs and vendors; for outsourced studies, support management of the CRO Project Manager to drive performance, while documenting oversight in line with SOPs and transfer-of-obligations requirements.
• Plan and conduct internal and external meetings, such as Investigators’ and Monitors’ meetings, to align stakeholders, compress decision cycles, and expedite study milestones.
• Liaise with Clinical Supply Chain and external providers to ensure uninterrupted supply of investigational product and study materials, anticipating needs and solving bottlenecks before they affect sites or patients.
• Proactively identify risks and issues; develop mitigation and action plans that protect data integrity, patient safety, and delivery commitments—keeping studies inspection-ready at all times.
• Ensure that all study documents within scope are complete and quality-verified in the Trial Master File, enabling traceability and audit readiness.
• Support GSD and/or GSAD with budget management, including external service provider invoice reconciliation, linking spend to milestones and value.
• Support overall project management as delegated, bringing cadence, transparency, and problem-solving to cross-functional teams.
• Take on non-drug project work to improve processes and lead improvement initiatives—translating lessons learned into scalable practices that accelerate future studies.
• Adhere to global clinical processes, procedural documents, Quality & Compliance manual documents, and ICH/GCP, ensuring consistent, inspection-ready execution across the study lifecycle.

Benefits

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

What This Job Offers

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