Senior Manager, Clinical Study Lead
Core
Lead global execution of large and complex clinical trials in Inflammation & Immunology from design to close-out, managing timelines, budget, and cross-functional teams.
Role type
Senior Manager, Clinical Study Lead
Builds
Global clinical trials for Inflammation & Immunology medicines
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global clinical trial operations, line management, protocol development, risk assessment, vendor management, patient recruitment strategies, study close-out management, budget and timeline management
Preferred skills
Experience with outsourced studies to CROs, feasibility assessment, site activation monitoring, drug accountability
Technologies
CTMS, TMF, IVRS/IWRS, EDC, MS Project, PowerPoint, Word, Excel
Responsibilities
Lead cross-functional study teams and serve as primary point of contact for assigned studies; Oversee development of study documentation including CRFs, data management plans, and statistical analysis plans; Manage vendor engagement, contracting, and oversight; Develop and implement patient recruitment and retention strategies; Supervise CTM staff including performance management and professional development; Execute study close-out activities including database lock and contract reconciliation.
Seniority
Senior, hands-on IC with line management responsibilities
