Site Name: UK – London – New Oxford Street, Italy – Siena, UK – Hertfordshire – Stevenage
Posted Date: May 8 2026
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 will take ownership of crafting robust, accelerated delivery plans designed to achieve top‑tier performance—ensuring timelines, quality standards, and ambitious targets are consistently met.
Collaborating closely with the Global Study Lead (GSL), you will 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 dynamic and impactful role is designed for individuals driven to make a meaningful difference in clinical operations.
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, a pension plan, and a shares and savings programme. Our Performance with Choice programme provides a hybrid working model, allowing you to balance remote and in‑office work.
Responsibilities
- Lead the Working Group (WG) for Clinical Operations, ensuring operational delivery of clinical studies to time, quality, and budget, in line with company standards and scientific requirements.
- Be 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
- Vendor 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
- Support assessment and selection of FSO vendors.
- Provide holistic oversight of FSO vendors according to the FSO handbook.
- Assess and select other study vendors under GCSD responsibility in consultation with the GSL.
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies.
- Balance risk/benefit to make decisions based on a clear understanding of impact on the study and project.
- Proactively identify, oversee, and mitigate study risks.
- Ensure appropriate stakeholder communication, including study status, expectations, risks, and issues.
- Operate within the study budget.
- Effectively lead empowered matrix teams.
- Implement innovative approaches to study delivery through external-facing advances in technology and science, encouraging others to seek innovative perspectives and solutions.
- Provide operational input into protocol and informed consent form development and other key study documents.
- Lead and conduct investigator meetings and other study‑related meetings.
- Lead quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.
- Ensure data quality plans and end‑to‑end data cleaning are performed by the responsible line functions.
- Ensure the Clinical Study Report is delivered on time and support GSK’s adherence to local regulatory guidance.
- Oversee the activities of the countries participating in the study.
- Provide support and coaching (where appropriate) to the SM.
- Advocate the use of AI/ML tools, driving automation of manual processes, and finding efficiencies and more effective ways of working.
Qualifications
- Bachelor’s degree in life sciences or a related discipline.
- Good understanding of complex clinical development and regulatory processes.
- In‑depth experience in clinical research, including study management, monitoring, and data management.
- Strong project management skills and experience with project management tools.
- Proven ability to execute operational tasks and deliver studies on schedule.
- Experience working across multiple types of study designs.
- In‑depth knowledge of GCPs and ICH guidelines.
- Excellent stakeholder management and communication skills (oral and written) and outstanding interpersonal skills.
- Demonstrated leadership skills, promoting motivation and empowerment of others.
- Strong understanding of clinical study processes, drug development, sample management, and associated quality requirements, including ICH/GCP guidelines and SOPs.
- Proficient project management, including scope, budget, timeline, and resource planning and management.
- Ability to lead and work within teams and networks across functional and geographical boundaries, leading by example and promoting collaboration and effective communication.
- Ability to manage competing priorities, performance targets and project initiatives in a global environment.
- Operational expertise in risk management and contingency planning.
- Application of industry best practices to design and execute clinical studies to improve time and cost efficiency.
- Strong conceptual, analytical and critical thinking skills.
- Effective problem‑solving and conflict‑resolution abilities.
- Ability to manage change and uncertainty.
- Ability to delegate tasks.
- Experience in multicultural settings with diverse work environments.
- Versatility and adaptability across multiple therapeutic areas.
- Independent, systematic, creative problem‑solving with a risk‑based approach.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants 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, military service or any basis prohibited under federal, state, or local law.
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