Study Manager

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About the role

Business Introduction 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 position within GCSD works cross- functionally within internal (e.g. LOC) and external partners (e.g. vendors) to deliver delegated operational tasks from CSI (Commit to Study Initiation) until study archiving to time, quality, budget, company standards and scientific requirements as outlined in the clinical study protocol. The SM is accountable for delivery of delegated operational tasks to time, quality, budget, company standards and scientific requirements, supporting decision making at pace and supporting study teams to achieve overall study deliverables in consultation with the Global Study Lead (GSL) and Global Study Manager (GSM). The SM as Scrum Master is responsible for effective implementation of STOM ways of working and facilitation of key STOM ceremonies. The SM collaborates closely with Study Leadership Team (SLT) and Working Group (WG) Leads to proactively identify and address obstacles that may impede the study team's progress. Additionally, the SM ensures transparency and alignment across stakeholders by guiding the team in the effective use of collaborative tools (e.g., Jira or other platforms) to track progress, manage workflows, and foster communication. Responsibilities • SM works in close partnership with the GSL and GSM on end-to-end operational study delivery activities, from study setup to study archival, with the focus on overseeing SDS activities and ensuring completeness of internal systems/databases/tracing tools and project plans (CSAP). • SM works cross functionally, with internal and external team members, in accordance with STOM framework, current clinical study regulations and GSK procedures, policies, best practices and standards, and plays a key role in successful study delivery,providing subject matter expertise across key processes and systems throughout the life cycle of the study. • Clinical study management activities in scope of the SM may include any of the following, agreed in partnership with the GSM and GSL:   • Monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline and budget objectives and maintaining systems. • Reviewing and leading development of key clinical documents and manuals, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan, Pharmacy Manual etc.) for external and internal use in assigned studies. • Facilitating and maintaining interactions and meetings with internal (including but not limited to regulatory, LOC, quality assurance, Monitors meeting/Investigators’ Meeting, STOM Ceremonies) and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies. • Support GSM in CRO oversight, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties • Vendor management-cou

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