Global Study Manager

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About the role

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 is accountable for delivering the clinical operation activities of the study / studies from CSI (Commit to Study Initiation) until study archiving.  This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality.  The GSM role works in consultation with the Global Study Lead (GSL) for end-to-end delivery of the clinical study.    Key responsibilities include, but are not limited to:   • 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):  o   Study Initiation Meeting​  o   Clinical Study Activity Plan ​  o   Study Delivery Plan​  o   TMF Quality Strategy Document ​  o   DCT Set Up​  o   Study Demographic and Diversity Plan ​  o   Vendors Oversight Plan​  o   Results Dissemination Plan ​  o   Investigator/CRA Meeting Set Up & associated training​  o   Expected Document List​  o   Recruitment Tracking​  o   Budget tracking eTMF filing and Vendor Set Up and Management​  o   Patient Engagement Activities​  o   CSDD KOM & template​  o   Safety Management plan​  o   Protocol Deviation Management Plan​  o   eTMF & vendor set-up​  o   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

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