Manager, Clinical Study Lead
Core
Lead assigned clinical trials from study design through close-out for Japan operations, collaborating with cross-functional teams and vendors.
Role type
Senior Clinical Study Lead (Manager level)
Builds
Global, regional, or country execution of clinical trials
Domain
Biopharmaceuticals / Clinical Operations
Required skills
Clinical trial operations, protocol design, budget management, vendor management, regulatory compliance (ICH GCP), trial management systems, project management, cross-functional leadership
Preferred skills
Data-driven thinking, process improvement, staff leadership
Technologies
Trial management systems, Interactive Voice Response Systems, electronic data capture
Responsibilities
Lead cross-functional study teams and global/regional/country execution of assigned clinical trials; Shape protocols, study documentation, feasibility, site selection, investigator meetings and recruitment strategies; Manage timelines, budgets, risks, vendors, supplies, study systems, activation, monitoring and data quality; Maintain Clinical Trial Management System and Trial Master File readiness, including registry, audit and inspection compliance; Escalate study issues and implement corrective actions with Program Operations Lead, Country Operations Lead and stakeholders; Lead close-out, including database lock, vendor reconciliation, budgets, Trial Master File and study drug accountability; Support study reports, lessons learned, staff deliverables, process improvement, unmasked activities and potential line management
Seniority
Senior, hands-on IC with management responsibilities