Global Study Manager

AstraZeneca; Mississauga; On-site; CAD 80,000 - 100,000; Full time

Job summary

A global biopharmaceutical company is seeking a Global Study Manager to lead the delivery of clinical studies. The role includes overseeing study execution, managing relationships with external service providers, and ensuring compliance with international guidelines. Candidates should have a university degree and relevant experience in the pharmaceutical industry. This position is critical to driving excellence in clinical study execution, and offers opportunities for process improvement and career growth.

Benefits

Top Employer Award for 10 years

Top 100 Employers Award

Canada’s Most Admired Corporate Culture

Qualifications

• University degree or equivalent experience in medical or biological sciences preferred.
• Relevant experience in the pharmaceutical industry or academia, preferably at least 3 years.
• Knowledge of clinical development/drug development processes.

Responsibilities

• Oversee study delivery in partnership with internal and external teams.
• Prepare study documents and manage service provider materials.
• Ensure all study documents are complete and verified for quality.

Skills

Communication and relationship building

Project management

Collaboration

Computer proficiency

Leadership skills

Education

University degree in medical or biological sciences

Advanced degree or equivalent experience

Job description

Overview

Are you ready to make a significant impact in the world of clinical research? As a Global Study Manager, you will be an integral part of the extended global study team, ensuring the successful delivery of clinical studies within BioPharmaceuticals Clinical Operations. From the development of Clinical Study Protocols to study archiving, you will work cross-functionally with internal and external partners to drive excellence in clinical study execution. Your position will be essential in maintaining AstraZeneca's values and adhering to international guidelines and regulations.

Responsibilities

• In partnership with AstraZeneca teams, clinical experts, and external service providers, you will oversee study delivery.
• Lead and contribute to the preparation of study documents and external service provider-related materials.
• Maintain and facilitate interactions with internal and external functions to ensure efficient study delivery.
• Contribute to the planning and conduct of internal and external meetings.
• Ensure the supply of investigational products and study materials by liaising with relevant parties.
• Proactively identify risks and issues, developing mitigation plans as needed.
• Ensure all study documents are complete and verified for quality in the Trial Master File.
• Support budget management and invoice reconciliation.
• Adhere to global clinical processes and international guidelines to ensure inspection readiness.
• Support overall project management as per agreed delegation.
• Manage outsourced studies, ensuring delivery according to timelines, budget, and quality standards.
• Take on assignments in process improvements or leading improvement projects.

Essential Skills/Experience

• University degree or equivalent experience, preferably in medical or biological sciences or field associated with clinical research.
• Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
• Knowledge of clinical development/drug development process in various phases of development and therapy areas.
• Excellent knowledge of international guidelines ICH/GCP.
• Excellent communication and relationship building skills, including external service provider management skills.
• Good project management skills.
• Demonstrated ability to collaborate as well as work independently.
• Demonstrated leadership skills.
• Computer proficiency, advanced computer skills in day-to-day tasks.
• Excellent verbal and written communication in English.

Desirable Skills/Experience

• Advanced degree or equivalent experience.
• Experience in all phases of a clinical study lifecycle.
• Basic knowledge of GXP outside of GCP (i.e., GMP/GLP).

Great People to Work With

• Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ, apply today!

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 [e-mail].

Date Posted

23-Sept-2025

Closing Date

29-Sept-2025

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.