Clinical Trial Project Manager - Neuroscience - Cincinnati
Core
Manage day-to-day operations of clinical trials for biotech and pharmaceutical companies, ensuring compliance with ICH/GCP regulations and serving as the primary contact for sponsors.
Role type
Mid-level clinical trial project manager (Neuroscience/CNS)
Builds
Clinical trial studies for biotechnology, pharmaceutical, and medical device industries
Domain
Clinical research / Neuroscience
Deliverable
client delivery
Required skills
Project management, risk assessment, vendor management, site quality oversight, protocol review, cross-functional team leadership
Preferred skills
Advanced degree in health-related field, experience in Phases 2-3 clinical trials
Technologies
ICH/GCP guidelines, clinical trial management systems
Responsibilities
Manage and provide accountability for day-to-day operations of the project, 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, Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, 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