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 operational project-specific issues and study deliverables
Maintain in depth knowledge of protocol, therapeutic area, and indication
Provide cross-functional oversight of internal 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 execution
Manage study vendors where applicable
Manage site quality and monitoring deliverables
Education, Qualifications, and Experience
Bachelor's degree in a health-related field; Advanced degree in a health-related field preferred
Experience in Phases 1-4; Phases 2-3 preferred
5+ years as a project/clinical trial manager within a CRO