1. Line Management
• Responsibility for the appraisal of direct reports with strong emphasis on clearly defined and agreed objective setting and review.
• Development and implementation of a comprehensive and focussed training program for each line report, covering both formal training and ‘on the job’ mentoring and support.
• Provide formal induction training to any new line report.
• Assist in recruitment of new team members based on resource requirements.
• Coordinates and participates in the motivating, mentoring, training and support of all line reports.
• Ensure effective communication within the team, through regular meetings to encourage shared learning and implementation of best practice and development of systems/practices to further improve the efficiency of the service offered.
• Communicates implementation of new procedures within the department.
• Manage day-to-day operations related to direct reports, including ensuring accurate timesheet coding, leave management, SOP updates and training, direct report CVs/training records updates and claims review and approvals.
2. Projects
• Review & report to the Clinical Operations Head, project status for projects involving clinical staff within the team against agreed deliverables and customer expectations.
• Assist staff responsible for the projects to identify and address issues proactively.
• Ensure projects within the team are managed in accordance with the Clinical Operations standard operating procedures.
• Serve as a CTL on global/regional/local projects or Project Manager for select projects. Performing these roles as described in the relevant position descriptions
3. Clinical Operations
• Maintains awareness of overall development in the field of clinical research, including application of new technologies, as well as knowledge of assigned therapeutic areas, by reading related literature, attending professional meetings, etc.
• Identifies and records non-conformity with Company procedures and SOPs, and recommends and implements corrective and/or preventative action. Ensuring that conformity occurs.
• Ensure clinical operations procedures and processes are both efficient and effective at meeting the company and international standards.
• Perform activities associated with clinical monitoring (site selection, initiation, monitoring and close-out) as required.
• Perform administrative duties as required, including serving on regional/global clinical operations committees.
• Drives the maintenance of a detailed Investigator database, working with team members to continually build the database.
• May be assigned to other internal projects and may perform other duties assigned by line management.
4. Business Development
• Assist the Business Development department through review of proposals and project costing, providing assistance in the planning of project strategies for proposals, co-ordination of feasibility requests, attendance at client meetings (as appropriate) and promotion of South East Asia Operations to internal and external customers.
경력 및 자격요건
-제약회사 또는 CRO회사에서 최소 5년 이상 CRA 경력자
-모니터링 능숙하고 국내외 임상실험에 관련된 법규에 대한 지식 보유자
-의약품 개발 과정에 대한 지식 보유자
-영어 의사소통 능숙한 자
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자