Global Study Manager

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About the role

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'll take ownership of crafting robust, accelerated delivery plans that aim for top-tier performance—ensuring timelines, quality standards, and ambitious targets are consistently achieved. Collaborating closely with the Global Study Lead (GSL) , you'll 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 is a dynamic and impactful role designed for individuals driven to make a meaningful difference in clinical operations. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • 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): - Study Initiation Meeting​ - Clinical Study Activity Plan ​ - Study Delivery Plan​ - TMF Quality Strategy Document ​ - DCT Set Up​ - Study Demographic and Diversity Plan ​ - Vendors 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 ​ - 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 ef

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