Senior Manager, Clinical Study Lead
Core
Lead complex clinical trials from study design through close-out, managing cross-functional teams, vendors, and CROs to deliver life-changing medicines.
Role type
Senior Manager, Clinical Study Lead
Builds
Global, regional, and country clinical trial studies
Domain
Biopharmaceuticals / Clinical Operations
Required skills
Clinical trial operations leadership, ICH/GCP regulatory knowledge, project management, budget management, vendor/CRO management, trial management systems proficiency, data quality monitoring, site selection and activation, patient recruitment strategy, close-out management
Preferred skills
Line management experience, advanced proficiency with IVRS/IWRS and EDC, ability to build and develop study teams
Technologies
CTMS, TMF, IVRS/IWRS, EDC
Responsibilities
Lead cross-functional teams and global trial delivery; Own timelines, budgets, risks, and study documentation; Oversee vendor and CRO management and audit readiness; Direct feasibility, site selection, and patient recruitment; Monitor data quality and trial performance; Manage close-out and clinical study reports
Seniority
Senior, hands-on IC with line management responsibilities
