주요업무
• Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
• Serve as primary Sponsor contact for project-specific issues and study deliverables
• Maintain in depth knowledge of protocol, therapeutic area, and indication
• Provide cross-functional oversight of project team members and deliverables, which includes ensuring all necessary project-specific training is provided
• Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
• Develop operational project plans
• Manage risk assessment and mitigations
• Manage study vendors
• Manage site quality, including direct supervision of project Clinical Research Associates (CRA) and monitoring deliverables