Clinical Trial Manager - Neuroscience/Ophthalmology/Infectious Disease

Clinical Trial Manager - Neuroscience/Ophthalmology/Infectious Disease

Medpace

Madrid, Spain

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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