.The Global Study Manager (GSM) is responsible for the operational planning, management & execution of clinical study and program(s) within Trial Operations.The GSM is the leader of the clinical study team and is empowered to drive the management & delivery of the study team operational objectives, ensuring all trial deliverables are met according to the study timelines, within budget, and having the highest quality standards (GCP / ICH, SOPs / QDs).The GSM leads the preparation of study-related plans and materials, identification of study risks and contingency planning, appropriate escalation of issues, monitors the study planning, manages budget to ensure it is kept within budget, and leads the execution of the study with integrity and suitability for regulatory review.The GSM leads cross-functional study teams, responsible for the coordination of internal/external resources, organization of internal team meetings, and drives and oversees vendors for the flawless execution of studies.Responsible for the management of Clinical and Medical Service Providers, set up & oversight of service providers, and ensures adherence to the scope of work within timelines and budget.The scope of this position requires excellent communication skills (written and oral), a critical-thinking/problem-solving mindset, and strong leadership to manage across functions and drive the operational success of study activities.MAIN RESPONSIBILITIESLeads the Study Team on the Planning and Execution of Clinical Studies: Lead the study team (including representatives from CSUs/affiliates/vendors, Data Management, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics, and other relevant departments) for the operational aspects of the study. Liaise with the feasibility manager to review and assess feasibility. Liaise with clinical buyers to prepare the RFP (request for proposal), review the proposal, and participate in the selection of the vendor(s). Liaise with Operational Excellence Center (OpExC) contributors for vendors' activities and deliverables, directly oversee activities and deliverables for vendors not covered by OpExC to ensure performance expectations are met. Ensure study progress is aligned with projections: drive and oversee study timelines, track budget, and escalate risks to timelines and budget as needed. Communicate changes and progress.Ensure proper documentation/availability: Develop following study documents as the author: Monitoring Plan, Study Communication Plan, Study Risk Management Plan, and any study operational material (e.G. Study newsletters, memo, etc.) as needed; Co-develop documents with vendors (if OpExC is not involved): specifications of central services, scope of work, operational manual, etc. in conjunction with the study team
