Study Manager
Listed on 2026-09-23
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Research/Development
Clinical Research, Regulatory Compliance Specialist
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.
We’re uniting science, technology, and talent to get ahead of disease together. Find out more:
Our approach to R&D
The Study Manager role will provide end-to-end study management support for GCC Study Delivery, focusing on Canada-based activities. This role is responsible for leading or supporting clinical studies so that they are initiated, executed, and delivered to agreed quality, timelines, and budget, while ensuring compliance with GSK policies, SOPs, and regulatory requirements.
ResponsibilitiesThis role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Lead or support the planning, set‑up, execution, and close‑out of assigned clinical studies, ensuring delivery to agreed timelines, quality standards, and budget.
- Coordinate cross‑functional study teams (e.g. Clinical Operations, Data Management, Biostatistics, Medical, Quality) and maintain clear communication of study progress, risks, and mitigation plans.
- Oversee operational aspects of site and patient management across assigned studies, including start‑up activities, recruitment, monitoring, and issue escalation.
- Ensure studies are conducted in accordance with ICH‑GCP, Health Canada and other applicable regulations, GSK SOPs, and internal quality standards.
- Contribute to protocol, study plans, and key study documentation; support inspection readiness and respond to audit/inspection findings as needed.
- Identify operational risks and issues; propose and implement mitigation strategies to maintain delivery against tight timelines for newly acquired and existing assets.
- Collaborate with line managers and study teams in Canada and globally to share best practices and continuously improve study delivery processes.
- Support onboarding and mentoring activities for new team members, including serving as a peer buddy where appropriate.
This role is hybrid. You will be expected to work regularly from a GSK office in Canada and collaborate with colleagues across time zones.
Basic QualificationsWe are seeking professionals with the following required skills and qualifications to help us achieve our goals
- Bachelor’s degree in life sciences, health sciences, pharmacy, nursing, or a related discipline (or equivalent experience).
- 3 years of relevant experience in clinical operations, study management, or pharmaceutical project management.
- Demonstrated hands‑on experience leading or coordinating clinical studies such that the candidate can join an active study and contribute independently after a short ramp‑up.
- Practical knowledge of study processes across start‑up, conduct and close‑out.
- Understanding of clinical research regulatory requirements and Good Clinical Practice (GCP).
- Proven ability to manage multiple priorities, plan work and meet deadlines.
- Proficiency with Microsoft Office and experience using clinical trial management tools or trackers.
If you have the following characteristics, it would be a plus
- Experience working in a global pharma or CRO environment with cross‑functional, matrixed teams.
- Experience with Health Canada or North…
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