Director/Manager of Phase I Clinical Operations

KSR Clinical Research has a great leadership opportunity for a highly qualified professional in Miami, FL to work for one of the leading CROs in the world. The Manager/Director of Phase I Operations is responsible for the strategic direction of the Phase I division within this CRO and interacts with the CEO, Principal and Sub-Investors, Executive management and internal staff in all departments.Qualified candidates will have the following knowledge, skills and experience:' Bachelor of Science, Post-Secondary Diploma in scientific, healthcare, or pharmaceutical field, or equivalent.' 8-10 years experience in a healthcare/clinical research environment (5 years of which are working in Phase I clinical research in a CRO setting).' 2-4 years of experience in a management role.' Bilingual (Spanish)The Manager/Director of Phase I Operations is responsible for:' Oversight of all aspects of Phase I trials.' Develop and implement strategic plans for Clinical Operations Division.' Assist in the assessment of potential clinical trials and business opportunities.' Monitor departmental spending per established budget.' Work with Finance during the budgeting process to develop the departmental budgets.' Participate in corporate Shared Resource Planning and Project Planning Meetings to ensure Phase I study requirements are addressed and planned for appropriately.' Create, maintain and report quarterly metrics.' Monitor staff workloads and productivity including regular meetings with Supervisors.' Regularly meet with and give updates to the Managing Director.' Stay current with regulatory requirements (TPD, FDA, EMEA, ICH, etc.)' Cooperate with the Director of Quality Assurance & Regulatory to develop and ensure quality within the Phase I Division.' Ensure compliance with appropriate SOP, GCP, and ICH guidelines.' Supervise and provide work direction for other managers and supervisors.' Execute other duties as may be required. Learn more about company