Clinical Trails Manager - Katalyst Healthcares & Life Sciences
Cincinnati, OH 45201
About the Job
Responsibilities
- 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
- 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
Source : Katalyst Healthcares & Life Sciences