Responsibilities:

• Provide site management oversight, clinical monitoring, and central monitoring deliverables
• Review study scope of work, budget, and protocol content
• Identify risks to clinical trial management deliverables and escalate to project manager
• Employ strategic thinking and problem-solving skills to propose and implement risk mitigations
• Serve as an escalation point for communications with investigator site staff
• Collaborate with other functional leaders to coordinate delivery handoffs and meet expected study milestones
• Develop and maintain clinical study tools and templates
• Coordinate training to the study team
• Oversee resourcing allocations for CRAs and Central Monitors
• Review project oversight dashboards and other clinical trial systems
• Understand the monitoring strategy required for the study
• Review content and quality of site and central monitoring documentation
• Interact with the client and other functional departments
• Demonstrate understanding of other functions' roles in achieving compliance and delivery
• Oversee CRAs and Central Monitors assigned to the study
• Provide feedback to line managers on staff performance

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Demonstrated ability to lead and align teams in the achievement of project milestones
• Demonstrated capability of working in an international environment
• Demonstrated expertise in site management and monitoring (clinical or central)
• Preferred experience with risk-based monitoring
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills
• Strong conflict resolution skills
• Moderate travel may be required, approximately 20%

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