대기업.Clinical Research Physician - Rheumatology
페이지 정보
등록자 :
강대필상무
등록일 : 14-09-01 00:00
기본정보
대기업.Clinical Research Physician - Rheumatology | |||
임상 | 팀장~임원 | ||
무관 | 무관 | ||
서류전형 -> 1차면접 -> 2차면접 | |||
상세정보
본문Major Responsibilities The duties assigned to Clinical Research Physician are as follows: Providing scientific and medical knowledge to generate clinical development plan (CDP) for each product in various stages of clinical development Scientific & clinical discussion and negotiation on clinical development with major regulatory authorities including US FDA and EMA Providing medical and scientific expertise for generation of clinical study protocols, data management plan, statistical analysis plan Cooperative work on the preparation and execution of clinical trials with clinical development team and RA team Medical consultation and decision making for ongoing clinical trials in therapeutic areas of expertise Review and analysis of clinical study results and supervision of clinical study reports Scientific support for IND & MAA process Contribute to the training and education of medical and scientific issues for internal staff Ensures that all established timelines and quality standards are met. Supports SOPs, Good Clinical Practices, and all work processes to ensure an efficient and compliant clinical operation. Works with clinical research personnel in reviewing laboratory data, performing physical assessments, medical histories, and evaluation of inclusion/exclusion criteria for study volunteers. Liaises with the Hospital in their areas of expertise and joint projects. Follow processes and adhere to Samsung and project specific standards as well as Health Authority requirements (SOP''s, Statistical Analysis Plan, GCP and regulatory guidelines). Establish and maintain sound working relationships and effective communication within the Medical team and with other teams.
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