Manager, Clinical Study Lead
Core
Accountable for the global execution of assigned smaller or less complex clinical trials from study design through execution to close out.
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, ICH/GCP compliance, budget management, vendor/CRO management, trial management systems, project management, cross-functional team leadership, site evaluation and selection, patient recruitment strategies, study close-out management
Preferred skills
Process improvement initiatives, risk assessment and mitigation, protocol development input, feasibility assessments
Technologies
CTMS, TMF, IVRS/IWRS, EDC, Microsoft Project, PowerPoint, Word, Excel
Responsibilities
Lead cross-functional study teams and serve as primary point of contact for leadership; oversee execution against timelines, deliverables, and budget; provide operational input into protocol development and lead feasibility assessments; oversee study documentation and study systems setup; identify outsourcing needs and manage vendor engagement; manage baseline budget and timeline development; lead study-level risk assessment and patient recruitment strategies; manage study close-out activities; supervise Clinical Study Management staff and support their deliverables.
Seniority
Manager, direct leadership of staff