Manager Clinical Study Lead
Core
Accountable for the global execution of assigned smaller or less complex clinical trials from study design through close out, ensuring conduct per SOPs and ICH/GCP.
Role type
Manager, Clinical Study Lead
Builds
Clinical trials (internally sourced and outsourced to CROs)
Domain
Biopharmaceuticals / Clinical Operations
Required skills
Global clinical trial operations, Protocol development, ICH/GCP knowledge, Project management, Cross-functional team leadership, Vendor management, Budget management, Trial management systems proficiency
Preferred skills
Process improvement, Risk assessment, Patient recruitment strategies, Study close-out management
Technologies
CTMS, TMF, IVRS/IWRS, EDC, Microsoft Project, PowerPoint, Word, Excel
Responsibilities
Lead cross-functional study teams and oversee execution against timelines and budget; Provide operational input into protocol development and lead feasibility assessments; Oversee study documentation, systems setup, and compliance with registry requirements; Identify outsourcing needs and manage vendor engagement and contracting; Manage baseline budgets and scope change control; Lead risk assessment, site activation monitoring, and patient recruitment strategies; Manage study close-out activities including database lock and contract reconciliation; Supervise Clinical Study Management staff and drive process improvements.
Seniority
Manager, direct leadership & oversight