Global study manager
Core
Drive clinical operations for assigned studies from Commit to Study Initiation through archiving, ensuring delivery to time, quality, and budget.
Role type
Senior Global Study Manager (Clinical Operations)
Builds
Clinical study deliverables including Study Initiation Meetings, Delivery Plans, TMF Quality Strategies, and DCT setups.
Domain
Biopharmaceuticals / Clinical Research
Required skills
Clinical study management, Project management, Risk management, Vendor oversight, Regulatory compliance (ICH/GCP), Stakeholder management, Budget tracking, Team leadership, Data quality management, Protocol development support
Preferred skills
Experience with decentralized clinical trials (DCT), Multicultural team leadership, Automation/AIML tool utilization, Change management
Technologies
eTMF, Clinical study management tools, Project management tools
Responsibilities
Lead Operational Working Groups for in-house studies, Oversee FSO vendor assessment and selection, Ensure compliance with ICH/GCP guidelines and GSK SOPs, Manage study risks and mitigate issues, Lead investigator meetings and training, Ensure data quality and end-to-end data cleaning, Support Clinical Study Report delivery, Coach Study Managers (SMs), Implement innovative approaches to study delivery
Seniority
Senior, hands-on IC
