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 resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
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 deliverables
Central monitoring deliverables
Patient safety focus
Protocol/GCP/regulatory compliance
Data integrity
Risk-based monitoring
Nice-to-have
Agile and driven to deliver
Inclusive culture
Collaborative problem solvers
Continuous improvement
Key Requirements
Bachelor’s degree or RN in a related field
Demonstrated ability to lead and align teams
Expertise in site management and monitoring
Knowledge of Good Clinical Practice/ICH Guidelines