Clinical Research and Administration professional
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Strong organizational and planning. Equally effective working independently or as part of a team. Consistently meet tight deadline schedules within dynamic environments. Flexible when necessary to meet over-arching needs of the company. Disciplined, very thorough, conscientious and meticulous with work. Exceptional documentation. Comfortable interfacing with all levels of management. Excellent oral and written communication skills. Admirable customer service and interpersonal skills.
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 • Above average communication skills on both English language comprehension and English language production.
ICH/GCP and all other applicable laws, rules, and regulations
