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| Job #03036 |
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| About our client |
| Our client is one of the world’s leading providers of clinical research services to the life sciences industry. They have two sites consisting of a 213-bed capacity for Phase I/IIa studies and are ideal sites for Phase II – IV clinical trials. Our client is focused and committed to research and scientific excellence. With a strong management team in place and a large client base, this is an excellent opportunity for the right candidate to join a fast-paced and challenging environment. |
| Position |
Location |
| Director of Phase I Facility |
Miami, Florida |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Manage the Phase I Division at the clinical facility 2) Interact with the CEO, principal and sub-investigators, executive management, internal staff in all departments, etc. 3) Oversee all aspects of Phase I trials 4) Assist in assessing potential clinical trials and business opportunities 5) Monitor departmental spending as per established budget 6) Work with Finance (annually) during the budgeting process to develop departmental budgets 7) Participate in corporate-shared resource planning and project planning meetings to ensure Phase I study requirements are addressed and planned for appropriately 8) Create, maintain and report quarterly metrics 9) Monitor staff workloads and productivity (regular meetings with supervisors for study updates and review of professional development) 10) Prepare and conduct performance appraisals for direct reports 11) Meet regularly with and give updates to the Vice President Clinical Affairs and Operations with regard to clinical trials and staffing issues within the division 12) Participate and attend industry meetings, conferences and workshops 13) Remain current with regulatory requirements (TPD, FDA, EMEA, ICH, etc.) 14) Assist the Director of Quality Assurance and Regulatory Affairs to develop and ensure quality within the Phase I Division and the company
15) Ensure compliance with appropriate company SOPs, GCP and ICH guidelines 16) Participate in training sessions 17) Work in a safe manner 18) Strive to consistently uphold company core values 19) Provide work direction 20) Handle hiring, promotions, transfers, performance management, discipline and termination of employees 21) Perform other duties as required |
| Requirements |
1) BS or Diploma in a scientific, healthcare, pharmaceutical or any other relevant field 2) Minimum 5 years of experience in Phase I clinical research (in a CRO setting) 3) 8 – 10 years of experience in a healthcare/clinical research environment (preferably Phase I) 4) 2 – 4 years of experience in a management role 5) Strategic planning experience 6) Excellent organizational skills 7) Detail-oriented and efficient with ability to multi-task and prioritize effectively 8) Superb interpersonal and communication (verbal and written) skills 9) Good trouble-shooting and decision-making skills 10) Ability to escalate response to situations when needed 11) Strong project coordination/management and project-planning skills 12) Good people management and conflict resolution skills |

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