Clinical Project Manager

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Ophthalmology • Medical Device • Clinical Research • Contract Research Organization

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Description

•Act as a liaison with sponsor to oversee clinical studies to include: •Ensure study remains within scope and out of scope activities are identified and handled as appropriate •Perform risk management and contingency planning activities to ensure that all potential study risks, such as delays in study milestones and increased study costs, are managed in a proactive and efficient manner •Facilitate team coordination and work flow for projects •Develop and Monitor project timelines and resources allocated •Communicate up-to-date information regarding project progress to all relevant interested parties •Provide strategic input on enrollment and contingency planning •Vendor management to include procurement and negotiation of contracts •Lead project team meetings to ensure on-time deliverables •Assist in protocol development and CRF design •Track departmental carbon footprint and implement policies, procedures, and practices to decrease negative impact on the environment •Ensure all departmental purchases and practices reflect the company’s corporate citizenship policy •May manage clinical study budget and contracts

Requirements

•Knowledge of FDA and International Conference of Harmonization and Good Clinical Practices (ICH/GCP) Guidelines •Excellent written and verbal communication skills and detail-oriented skills •Various computer skills – Excel, Word, PowerPoint, Microsoft Outlook •Extensive understanding of principles, concepts, practices, and standards of clinical research •Excellent leadership skills •Excellent organizational skills, including the ability to handle multiple assignments •Possess full working knowledge of all required clinical study tasks and elements from study initiation through completion •Ability to ensure a good customer relationship is established and maintained