Global Study Manager
Core
Lead clinical operations for assigned studies from initiation to archiving, ensuring delivery to time, quality, and budget standards.
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
Pharmaceutical industry / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study management, Project management, Risk management, Vendor oversight, Protocol compliance, Budget tracking, Stakeholder communication, Team leadership, Regulatory knowledge (ICH/GCP), Data quality management
Preferred skills
Experience with FSO models, Automation/AIML tools, Multicultural team management, Innovative study delivery approaches
Technologies
eTMF, Clinical Trial Management Systems, Project Management Tools
Responsibilities
Lead Operational Working Group for in-house studies, Ensure compliance with ICH/GCP guidelines and GSK SOPs, Manage study risks and mitigate issues, Oversee FSO vendors and select study vendors, Lead investigator meetings and training, Ensure data quality and end-to-end data cleaning, Deliver Clinical Study Reports on time, Coach Study Managers, Drive adoption of AIML tools for process automation
Seniority
Senior, hands-on IC
