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Global Study Manager

Home / Global Study Manager

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Ville : Toronto

Catégorie : Autre

Industrie : Healthcare

Employeur : GSK

Nom du site: Mississauga Milverton Drive, USA - Pennsylvania - Upper Providence
Date de publication: Mar 16 2026

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


Position Summary

This role within GCSD plays a pivotal part in driving the clinical operations of assigned studies, from Commit to Study Initiation (CSI) all the way through to study archiving. As a Global Study Manager (GSM), you'll take ownership of crafting robust, accelerated delivery plans that aim for top-tier performance—ensuring timelines, quality standards, and ambitious targets are consistently achieved.

Collaborating closely with the Global Study Lead (GSL), you'll contribute to the seamless end-to-end delivery of the clinical study. As the GSM, you will lead the Operational Working Group (for in-house studies) and actively participate as a key member of the Central Study Team (CST). This is a dynamic and impactful role designed for individuals driven to make a meaningful difference in clinical operations.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • GSM will be the Working Group (WG) Lead for Clinical Operations with accountability for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision-making at pace and leading study team to achieve overall study deliverables

  • As Operational WG Lead, GSM is accountable for the following deliverables (to be adjusted accordingly for the STOM FSO model):

    • Study Initiation Meeting​

    • Clinical Study Activity Plan ​

    • Study Delivery Plan​

    • TMF Quality Strategy Document ​

    • DCT Set Up​

    • Study Demographic and Diversity Plan ​

    • Vendors Oversight Plan​

    • Results Dissemination Plan ​

    • Investigator/CRA Meeting Set Up & associated training​

    • Expected Document List​

    • Recruitment Tracking​

    • Budget tracking eTMF filing and Vendor Set Up and Management​

    • Patient Engagement Activities​

    • CSDD KOM & template​

    • Safety Management plan​

    • Protocol Deviation Management Plan​

    • eTMF & vendor set-up​

    • Pharmacy Manual ​

  • Supports assessment and selection of FSO vendors

  • Accountable for holistic oversight of FSO vendors according to the FSO handbook

  • Responsible for assessment and selection of other study vendors under GCSD responsibility in consultation with GSL 

  • Ensures compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies. understand study contribution to program/submission

  • Balances risk/benefit to make decisions based on clear understanding of impact on the study and project

  • Proactively and effectively identifies, oversees, and mitigates study risks

  • Ensures appropriate stakeholder communication, including study status, expectations, risks and issues

  • Accountable to operate within the study budget

  • Effectively leads empowered matrix teams

  • Implements innovative approaches to study delivery through external facing advances in technology and sciences and encourages others within matrix and line teams to seek innovative perspectives and develop solutions. 

  • Responsible for operational input into protocol and informed consent form development, and other key study documents.

  • Leads and conducts investigator meetings and other study related meetings

  • Leads quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies

  • Ensures data quality plans and end to end data cleaning is performed instream by the responsible line functions

  • Ensures Clinical Study Report is delivered on time and supports GSK’s adherence to local regulatory guidance

  • Oversees the activities of the countries participating in the study

  • Provides support and coaching (where appropriate) to the SM

  • Ambassadors in increasing utilization of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working

  • This role follows GSK’s Performance with Choice flexible‑working approach—balancing individual flexibility with team collaboration—and requires on‑site attendance 2–3 days per week to support core team activities and business needs. Candidates are required to live in proximity to a GSK hub.


Why You?
Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

Education Requirements:

  • Bachelor’s degree: life sciences or related discipline

  • The role will require a good understanding of complex clinical development and regulatory processes.

Job Related Experience:

  • In-depth experience in clinical research: study management, monitoring, data management

  • Strong skills and experience in project management and tools

  • Strong performer / executor of operational tasks with strong skills and experience in study delivery

  • Experience of working across multiple types of study designs

  • In depth knowledge of GCPs and ICH guidelines

  • Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills. 

  • Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives

  • Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs

  • Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)

  • Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others

  • Able to manage competing priorities, performance targets and project initiatives in a global environment

  • Operational expertise in risk management and contingency planning

  • Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency

  • Demonstrates conceptual, analytical and critical thinking

  • Effective at problem solving and conflict resolution

  • Ability to manage change and uncertainty

  • Ability to delegate tasks

  • Demonstrates experience in multicultural settings (to reflect our external customers/clients [health authorities/patients] and diverse environments with respect to dynamics of human interaction (including working with remote teams)

  • Demonstrates versatility and ability to adapt to working across multiple TAs

  • Ability to think independently, analyze and solve problems systematically and creatively, and to take a risk-based approach.


What we value
We look for people who are curious, accountable and collaborative. We support inclusion and welcome different perspectives. You will find learning opportunities and practical support to grow your career. If you enjoy clear, purposeful work that helps patients, we encourage you to apply.

How to apply
Please submit your CV and a brief cover note describing why this role matters to you and how your skills match the position. We look forward to hearing from you.

#LI-Hybrid

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 CAD117,000 to CAD167,000 , 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.

Pourquoi GSK?
Allier science, technologie et talent pour vaincre ensemble la maladie.

GSK est une entreprise biopharmaceutique mondiale dont la mission est de réunir la science, la technologie et le talent pour prendre ensemble de l'avance sur les maladies. Nous visons à avoir un impact positif sur la santé de 2,5 milliards de personnes d'ici la fin de la décennie, en tant qu'entreprise prospère et en croissance où les gens peuvent s'épanouir. Nous prenons de l'avance sur les maladies en les prévenant et en les traitant grâce à l'innovation dans les médicaments spécialisés et les vaccins. Nous nous concentrons sur quatre domaines thérapeutiques : les maladies respiratoires, l'immunologie et l'inflammation; l'oncologie; le VIH; les maladies infectieuses – pour avoir un impact à grande échelle sur la santé.

Les gens et les patients partout dans le monde comptent sur les médicaments et les vaccins que nous produisons; c'est pourquoi nous nous engageons à créer un environnement où nos employés peuvent s'épanouir et se concentrer sur ce qui compte le plus. Notre culture, qui repose sur l'ambition pour les patients, la responsabilité de la portée et le fait de faire ce qui est juste, constitue la base de la manière dont nous tenons nos engagements ensemble pour les patients, les actionnaires et nos employés.

GSK est un employeur offrant l'égalité des chances. Cela garantit que tous les candidats qualifiés recevront une considération égale pour l'emploi sans distinction de race, de couleur, de religion, de sexe (y compris la grossesse, l'identité de genre et l'orientation sexuelle), de statut parental, d'origine nationale, d'âge, de handicap, d'informations génétiques (y compris les antécédents médicaux familiaux), de service militaire ou de toute autre base interdite par la loi fédérale, étatique ou locale. GSK s'engage à accueillir les personnes handicapées. Si vous avez besoin d'un aménagement à n'importe quelle étape du processus de candidature ou si vous souhaitez plus d'informations sur nos politiques d'aménagement, veuillez nous contacter à canada-recruitment@gsk.com. Veuillez ne pas envoyer de CV à cette adresse e-mail et postuler plutôt via le processus de candidature en ligne de cette annonce.

Avis important destiné aux services/agences de placement

GSK n’accepte pas les propositions des services/agences de placement en vue de pourvoir les postes affichés dans le présent site. Ces services/agences doivent s’adresser au service d’approvisionnement/des ressources humaines de GSK pour obtenir une autorisation écrite avant de lui proposer des candidats. Cette autorisation est une condition préalable à toute entente (orale ou écrite) entre le service/l’agence de placement et GSK. Sans cette autorisation écrite, toute mesure de la part du service/de l’agence de placement doit être considérée comme avoir été appliquée sans le consentement ni l’entente contractuelle de GSK. Par conséquent, GSK ne peut pas être tenue responsable des honoraires attribuables à de telles mesures ni à quelque recommandation que ce soit de la part du service/de l’agence de placement en ce qui concerne sa proposition de candidature en vue de pouvoir un poste annoncé dans le présent site.

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