Clinical Research

• 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 site interactions post activation through site closeout
• May be responsible for identifying critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)
• Reviews study scope of work, budget, and protocol content and ensures clinical project team (CRAs/Central Monitors) is aware of contractual obligations and parameters
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget)
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
• Participates and presents in key meetings such as Kick Off Meeting
• Serves as an escalation point for communications with investigator site staff
• Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones
• Reviews and provides feedback on other functional plans as they relate to the clinical trial management activities
• Responsible for development and ongoing maintenance of clinical study tools and templates
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team

Clinical Trial Manager – Sponsor Dedicated

Principal Biostatistician