GSK is a science‑led global healthcare company with a special purpose: to help people do more, feel better, and live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade, focused on the discovery and development of groundbreaking vaccines and medicines, harnessing genetics and new data technologies.
Role Overview
We are seeking an experienced and highly motivated Global Study Manager (GSM) to lead the operational delivery of clinical studies, ensuring execution to time, quality, budget, and regulatory standards. The GSM will serve as the Working Group (WG) Lead for Clinical Operations, driving operational excellence, decision‑making at pace, and guiding a multi‑functional study team toward achieving all study deliverables.
Key Responsibilities
- Lead end‑to‑end operational delivery of clinical studies as the Operational WG Lead.
- Develop core study documents including activity plans, delivery plans, TMF strategy, and required operational materials.
- Oversee DCT setup, diversity planning, recruitment tracking, and protocol deviation management.
- Manage vendor selection, onboarding, oversight, and performance, including FSO vendors.
- Ensure timely eTMF filing, accurate budget tracking, and overall study readiness.
- Lead investigator meetings, CRA trainings, and other study‑related meetings.
- Ensure compliance with ICH‑GCP, regulatory requirements, and internal SOPs.
- Maintain inspection readiness and oversee data quality and cleaning activities.
- Identify and mitigate study risks, making balanced operational decisions.
- Provide clear stakeholder communication on study progress, risks, and expectations.
- Guide and motivate matrix teams; coach Study Managers when needed.
- Drive innovation through adoption of AI/ML tools and process automation.
- Provide operational input for protocols, ICFs, and other key study documents.
- Ensure timely completion of the Clinical Study Report and support regulatory submissions.
- Oversee operational activities across all participating countries to ensure alignment.
Requirements
- Bachelor’s degree in Life Sciences or a related discipline (advanced degree preferred).
- Strong understanding of clinical development processes, regulatory requirements, and global study operations.
- Proven experience leading complex clinical studies in a matrix environment.
- Exceptional communication, leadership, and stakeholder management skills.
- Demonstrated ability to drive innovation and operational efficiencies.
Inclusion at GSK
GSK is an EqualOpportunity/AffirmativeAction Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state or local protected class.
#J-18808-Ljbffr”, “datePosted”: “2026-05-12”, “hiringOrganization”: { “@type”: “Organization”, “name”: “Allegis Global Solutions”, “sameAs”: “https://uk.whatjobs.com/pub_api__cpl__429305053__4861?utm_campaign=publisher&utm_medium=api&utm_source=4861&geoID=33” }, “jobLocation”: { “@type”: “Place”, “address”: { “@type”: “PostalAddress”, “addressLocality”: “London” } } }GSK is a science‑led global healthcare company with a special purpose: to help people do more, feel better, and live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade, focused on the discovery and development of groundbreaking vaccines and medicines, harnessing genetics and new data technologies.
Role Overview
We are seeking an experienced and highly motivated Global Study Manager (GSM) to lead the operational delivery of clinical studies, ensuring execution to time, quality, budget, and regulatory standards. The GSM will serve as the Working Group (WG) Lead for Clinical Operations, driving operational excellence, decision‑making at pace, and guiding a multi‑functional study team toward achieving all study deliverables.
Key Responsibilities
- Lead end‑to‑end operational delivery of clinical studies as the Operational WG Lead.
- Develop core study documents including activity plans, delivery plans, TMF strategy, and required operational materials.
- Oversee DCT setup, diversity planning, recruitment tracking, and protocol deviation management.
- Manage vendor selection, onboarding, oversight, and performance, including FSO vendors.
- Ensure timely eTMF filing, accurate budget tracking, and overall study readiness.
- Lead investigator meetings, CRA trainings, and other study‑related meetings.
- Ensure compliance with ICH‑GCP, regulatory requirements, and internal SOPs.
- Maintain inspection readiness and oversee data quality and cleaning activities.
- Identify and mitigate study risks, making balanced operational decisions.
- Provide clear stakeholder communication on study progress, risks, and expectations.
- Guide and motivate matrix teams; coach Study Managers when needed.
- Drive innovation through adoption of AI/ML tools and process automation.
- Provide operational input for protocols, ICFs, and other key study documents.
- Ensure timely completion of the Clinical Study Report and support regulatory submissions.
- Oversee operational activities across all participating countries to ensure alignment.
Requirements
- Bachelor’s degree in Life Sciences or a related discipline (advanced degree preferred).
- Strong understanding of clinical development processes, regulatory requirements, and global study operations.
- Proven experience leading complex clinical studies in a matrix environment.
- Exceptional communication, leadership, and stakeholder management skills.
- Demonstrated ability to drive innovation and operational efficiencies.
Inclusion at GSK
GSK is an EqualOpportunity/AffirmativeAction Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state or local protected class.
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