Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
Job Summary
Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
Matching Summary
Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
Skills & Requirements
Must-have
site management oversight
clinical monitoring
patient safety
protocol/GCP/regulatory compliance
data integrity
risk-based monitoring
ICH GCP
Nice-to-have
agile and driven to deliver
inclusive culture
problem solvers
strategic thinking
Key Requirements
Bachelor’s degree or RN in a related field
Demonstrated ability to lead and align teams
Demonstrated capability of working in an international environment
Demonstrated expertise in site management and monitoring
Moderate travel may be required, approximately 20%