Study Manager

GSK; Mississauga; Hybrid; CAD 91,000 - 141,000; Full time

Job summary

GSK in Canada is seeking a Study Manager to provide end-to-end study management support for GCC Study Delivery, focusing on Canada-based activities. You will lead or support clinical studies to initiate, execute, and deliver with quality, on time and within budget.

The role requires collaboration with Clinical Operations, Data Management and other functions across Canada and globally, ensuring compliance with GSK policies and ICH-GCP, and supporting onboarding of new team members.

Qualifications

• Bachelor's degree in life sciences, health sciences, pharmacy, nursing, or a related discipline.
• 3 years of relevant experience in clinical operations, study management, or pharmaceutical project management.
• Demonstrated hands-on experience leading or coordinating clinical studies.
• 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.

Responsibilities

• Lead or support 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.

Job description

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.

Position Summary

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.

Responsibilities

• 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.

Working arrangement

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 Qualifications

• 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.

Preferred Qualifications

• Experience working in a global pharma or CRO environment with cross-functional, matrixed teams.
• Experience with Health Canada or North American clinical trial requirements.
• Strong understanding of ICH-GCP and applicable regulatory guidelines.
• Proven ability to manage multiple priorities, tight timelines, and complex stakeholders.
• Excellent communication and collaboration skills, with the ability to work effectively with Canada-based and international colleagues.
• Prior experience as a Study Manager, Study Lead, or equivalent role is strongly preferred

How We Work And What We Value

We welcome people from different backgrounds and life experiences. We support an inclusive workplace where everyone can contribute and grow. We look for colleagues who act with integrity, communicate openly, and support one another. You will find room to grow your skills, take on responsibility, and make a direct contribution to how we generate evidence.

• GSK uses artificial intelligence (AI) tools as part of the recruitment process to assist in screening and assessing applicants. Final hiring decisions are made by hiring managers, with support from recruiters.
• This advertisement relates to a current vacancy.

Skills

Agile Thinking, Business Acumen, Clinical Development, Clinical Research, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, Pharmaceutical Industry, Project Management, Time Management

In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD91,000 to CAD141,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [e-mail].