CO1 Director (Associate CO Director)
[담당업무]
Clinical operation 부서 관리 (산하 보직자: CRA, CRM)
업무내용
• Direct report to CR division Head
• Improve the operational systems, processes, and policies in support of organizations mission -- specifically, support better management reporting, information flow and management, business process and organizational planning.
• Manage and increase the effectiveness and efficiency of Services, through improvements to each function as well as coordination and communication between functions.
• Evaluate and recommend approaches to project management that will create opportunities to provide higher quality data or which will reduce the level of effort currently required;
• Target mechanisms and implement strategies for the ongoing assessment of performance through the use of metrics;
• Review and maintain job descriptions which allow for opportunity within division, clear understanding of job expectations, and appropriate level of job understanding and skill at the supervisory levels; this should be done in collaboration with other offices to ensure continuity;
• Assure appropriate guidelines for human resource functions (CRAs, CRMs) and supervisory responsibilities are followed and the personnel issues are appropriately handled. Foster corporate effort between project management, data management, and monitoring staff for both as well as with the remaining facilities;
• Oversee the Site Visit activity and ensure that identified critical issue was resolved with CRM.
• Actively participate in ongoing integration efforts with 0000 that will foster the best possible client service;
• Maintain adequate, qualified staff members to perform required project management functions; requirement efforts must be in accordance with budget standards and profitability considerations and human resource guidelines
• Coordinate clinical operation management training programs as well as other core staff training to ensure staff is provided a consistent level of quality; assure continuing education is provided to the staff to provide professional growth;
 Prepare and track departmental budget to assure aggressive growth in revenues and profitability is achieved while providing infrastructure to the department;
• Perform/review CRM profit management to ensure with an appropriate projected profitability;
• Coordinate development of appropriate guidelines and standard operating procedures to assure compliance with regulatory guidelines and to maximize efficiencies;
• Cooperate with BD team to make new contract and join to the bid defense meeting.
[필수사항]
- 학사이상(간호학, 약학, 생명과학, 보건학 등 임상관련 분야)
- 임상시험(CRA, PM, CRM) 실무 경력 10년 이상
- 상기 10년 경력 중 최소 CO팀장 경력 2년 이상 또는 부서장 경력 1년 이상
- 임상시험 전체 cycle(IND~NDA) 경험 및 실태조사 유경험자