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Clinical Trials Manager - Cincinnati, United States - INTELLECTT INC
Description
Position:
Clinical Trials Manager
Location
:
Cincinnati OH 45227
Duration
:
Full-Time
Work Type
:
Onsite/Hybrid
Job Description
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
Responsible for management of study vendor
Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables
Qualifications
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; required for home-based
Management of overall project timeline
Strong leadership skills
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