Peptilogics

Clinical Research

• Manage day-to-day operations of clinical trials, working closely with both the internal cross-functional study team and with the CRO team members
• Lead internal team meetings to provide study status updates
• Review study budgets and invoices. Track financial spending across vendors.
• Serve as the CRO primary point of contact for all day-to-day activities, including study startup, monitoring, site management, and close-out activities
• Monitor, track and report site and study performance metrics, budget and timelines. Review with Clinical Operations team and take needed steps to ameliorate when needed.
• Review monitoring trip reports and provide feedback to CRO as needed
• Ensure compliance with Good Clinical Practice (GCP), ICH, and regulatory requirements
• Serve as the Vendor point of contact for select vendors, ensuring deliverables are complete, of high quality and provided on time
• Provide regular updates and reports to stakeholders
• Oversee study team training records and ensure team members maintain current training status throughout the study
• Review TMF files to ensure TMF is complete and inspection ready
• Ensure study operations are compliant with study plans
• Work with the Sponsor and CRO teams to prioritize data integrity and participant safety
• Continuously monitor for quality issues and implement quality control measures as needed
• Perform other duties as assigned

Senior Clinical Trial Manager