임상 CTM 포지션 (영어 원어민 수준 소유자)
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CLINICAL TRIAL MANAGER Roles and responsibilities performed by the Clinical Trial Manager (CTM) are: - Supervise in-house clinical trial staff - Guide in the creation of important study documents - Conduct feasibility studies - Develop study budgets - Oversee patient recruitment - Ensure compliance of staff with the organizations Standard Operating Procedures - Conduct team meetings and staff training programs - Overall responsibility of the ongoing studies - Participate in protocol development, CRF design and clinical study report writing - Optimize costs and resources to help improve the organizations profitability Competencies & Skills: Various competencies and skills are required to become an efficient Clinical Trial Manager. Some of them are: - Thorough understanding of the drug development process with extensive knowledge of ICH-GCP - Extensive knowledge of clinical trial regulations such as those of US FDA, EMEA, DCGI etc - Influential & assertive communication skills - Excellent leadership skills - Good record keeping skills - Ability to motivate - Self Confidence - Ability to think Out-of-the-box - Problem solving skills - Conflict management skills - People management skills Education: - Bachelors or Masters degree in Pharmacy or any Science related field is highly recommende