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.
Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables and proposes and implements risk mitigations.
Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones.
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 mitigation strategies
client interaction
Nice-to-have
inclusive culture
career development
problem solvers
agile and driven
Key Requirements
Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
Demonstrated ability to lead and align teams
Demonstrated capability of working in an international environment
Demonstrated expertise in site management and monitoring
Knowledge of Good Clinical Practice/ICH Guidelines
Strong conflict resolution skills
Moderate travel may be required, approximately 20%