Linical

Clinical Research

• Develop site activation plans and customize study start-up documents
• Coordinate site identification, selection, and recruitment
• Oversee regulatory document collection, review, and ethics submissions
• Prepare and review essential study documents
• Authorize release of investigational product
• Coordinate site contracts and budget negotiations and manage investigator payments
• Manage clinical deliverables, milestones, timelines, and deficiencies
• Communicate with project managers, clients, and study teams
• Manage and train CRAs and other study team members
• Develop monitoring plans, tools, and training materials
• Oversee monitoring visit schedules and review visit reports, follow-up letters, expenses, and timesheets
• Perform quality assessment visits and remote clinical data review in EDC systems
• Conduct TMF quality-control reviews and ensure regulatory documents are filed appropriately
• Manage clinical vendor budgets, contracts, deliverables, and quality
• Assist with study budgets, expenses, revenue recognition, invoices, scope changes, and client notifications
• Perform site monitoring as required and attend investigator, kick-off, client, and project meetings
• Assist CRAs with on-site audits when needed
• Contribute to proposals, bid defense meetings, performance appraisals, and department training initiatives as applicable

Clinical Trial Manager