Global Study Manager

GSK is a science‑led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting‑edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre‑empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.

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.

Qualifications

• 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.

Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Inclusion at GSK

GSK is an Equal Opportunity/Affirmative Action 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.