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.
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Our approach to R&D
Position Summary
This position within GCSD is accountable for delivering the clinical operation activities of the study / studies from CSI (Commit to Study Initiation) until study archiving. This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality. The GSM role works in consultation with the Global Study Lead (GSL) for end-to-end delivery of the clinical study.
Key responsibilities include, but are not limited to:
- 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):
o Study Initiation Meeting
o Clinical Study Activity Plan
o Study Delivery Plan
o TMF Quality Strategy Document
o DCT Set Up
o Study Demographic and Diversity Plan
o Vendors Oversight Plan
o Results Dissemination Plan
o Investigator/CRA Meeting Set Up & associated training
o Expected Document List
o Recruitment Tracking
o Budget tracking eTMF filing and Vendor Set Up and Management
o Patient Engagement Activities
o CSDD KOM & template
o Safety Management plan
o Protocol Deviation Management Plan
o eTMF & vendor set-up
o 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
- Why You?
Work model: This role is hybrid; two to three days in our Mississauga office is expected. Travel within Canada and internationally will be required.
Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Minimum: 5+ years relevant clinical research / study operations experience (prefer 5; consider 7+ if progressing from a junior role).
- Demonstrated leadership/team‑lead experience (e.g., manager, country study manager, local delivery lead) - not solely administrative/CRO coordinator duties.
- Hands‑on experience across the study lifecycle: feasibility, start‑up/recruitment, vendor management and close‑out.
- Project management experience with timeline and budget oversight.
- Strong stakeholder and cross‑functional management (local or global); global experience preferred.
- Bachelor’s degree in life sciences or related discipline.
- Fluent English (strong written and verbal communication).
- Strong project planning, prioritization and decision‑making under uncertainty.
- Effective leader in matrixed, multicultural teams; coaches and empowers others.
- Analytical, risk‑based problem solver with excellent stakeholder communication.
- Adaptable to multiple therapeutic areas and study designs.
- Location: hybrid role - must live in proximity to a GSK hub.
Preferred QualificationsIf you have the following characteristics, it would be a plus:
- Cross‑modal experience and a solid understanding of clinical drug‑development (assessable in interview).
- Experience with eTMF, CTMS and digital/AIML tools.
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.
Ready to apply?
Please submit your CV and a short cover note describing why this role matters to you and how your skills match the position. We look forward to hearing from you.
- 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 Sciences, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, Pharmaceutical Industry, Project Management, Time ManagementIn 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.
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 canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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