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 identification of critical data and process, protocol execution risks and risk mitigations
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team is aware of the contractual obligations
• 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 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
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form completion, dashboards, etc.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintains proper visibility of its progress

Global Clinical Trial Manager II

Regional Clinical Study Manager

Senior Biostatistician – FSP

Clinical Trial Manager – FSP

Biostatistician II – Client Dedicated

Senior Biostatistician