生物医药临床项目经理
三生制药集团 查看所有职位BeijingUpdate time: August 26,2019
Job Description
职责描述：
1、负责并协调相关人员完成临床试验相关会议的开展，包括启动会、讨论会、数据审核会、总结会等；
2、制定项目计划及预算，实时跟进临床研究的执行进度，根据项目需要协调公司内部人员，管理试验相关外部单位（研究中心、数据、统计、分析等）的合同及进度；
3、保持与研究者协调联系，督促研究者及时完成数据收集及答疑；
4、协助医学经理完成临床方案的可执行性分析，及完善相关试验操作文件；
5、及时督促并协助研究者和监查员完成项目资料的收集和管理，确保试验严格按照GCP和国家要求进行；
6、病例审阅复核，避免方案偏移及未随访AE，及时收集并反馈试验过程中出现的操作偏移；
7、带教培训监查员熟悉项目执行及项目资料管理，有I期或BE项目经验优先。
任职资格：
1、本科及以上学历，临床、卫生、药学、药理、基础医学等相关专业；
2、3年以上临床项目经理经验，在CRO的项目经理经验优先，肿瘤、血液、内分泌、眼科、皮肤科、风湿等领域临床项目经验；
3、学习能力强，积极主动性好。
Responsibilities:
1. Responsible for coordinating and coordinating relevant personnel to complete the development of clinical trial-related meetings, including kick-off meetings, seminars, data review meetings, and summary meetings;
2. Formulate the project plan and budget, follow up the progress of the clinical research in real time, coordinate the internal personnel of the company according to the needs of the project, and manage the contract and progress of the relevant external units (research centers, data, statistics, analysis, etc.);
3. Maintain coordination with researchers and urge researchers to complete data collection and Q&A in a timely manner;
4. Assist the medical manager to complete the executable analysis of the clinical plan and improve the relevant test operation documents;
5. Promptly supervise and assist researchers and auditors to complete the collection and management of project materials to ensure that the tests are conducted in strict accordance with GCP and national requirements;
6. Case review and review, avoiding program offset and unfollowed AE, timely collecting and feedbackting the operational offsets that occur during the test;
7. The teaching and training inspectors are familiar with project execution and project data management. The experience of Phase I or BE projects is preferred.
Qualifications:
1. Bachelor degree or above, major in clinical, health, pharmacy, pharmacology, basic medicine, etc.;
2, more than 3 years experience in clinical project manager, project manager experience in CRO is preferred, clinical project experience in the fields of tumor, blood, endocrine, ophthalmology, dermatology, rheumatism, etc.;
3. Strong learning ability and good initiative.
职能类别： 生物工程/生物制药
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上班地址：远大中心
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