Clinical Trial Manager - Neuroscience/Opthalmology/Infectious Disease
Medpace
Lyon, France
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
Qualifications
- Bachelor’s degree in a health or life science-related field; Advanced degree in a health or life science-related field preferred;
- Experience in Phases 1-4; Phases 2-3 preferred;
- Minimum of 2 years of Clinical Trial Management experience, CRO experience preferred;
- 5+ years of Project Manager/Clinical Trial Manager experience at a CRO required for a remote-based role;
- Management of overall project timeline;
- Bid defense experience preferred; and
- Strong leadership skills
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