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 life-changing medicines in Inflammation & Immunology
Domain
Biopharma / Clinical Operations
Required skills
Global clinical trial operations, line management, study design, vendor management, risk assessment, patient recruitment strategies, budget management, regulatory compliance (ICH/GCP), clinical trial management systems (CTMS, TMF), data management, drug accountability
Preferred skills
Protocol development, strategic operational direction, stakeholder influence
Technologies
CTMS, TMF, IVRS/IWRS, EDC, MS Project, PowerPoint, Word, Excel
Responsibilities
Lead cross-functional study teams and manage direct supervision of CTM staff; Oversee study documentation, systems setup, and vendor engagement; Manage study timelines, budgets, and risk mitigation; Drive patient recruitment and retention strategies; Oversee study close-out activities including database lock and contract reconciliation.
Seniority
Senior Manager, direct leadership