吴先生
2天前在线
已认证
- 职位介绍
- 基本条件：英文流利；医师资格；博士；有CRP经验 Conduct frank discussions and set clear expectations for site performance and monitor site performance through metrics. Identify quality issues and discuss with clinical/operations study team members so that corrective actions may be instituted. Escalate protocol-related issues requiring medical expertise to the RCSL or medically-qualified China Clinical Program Lead, if needed. Escalate operational issues to the appropriate operations study team member. Identify the need for and provide supportive coaching and/or training to site staff, as appropriate. Education • Required: BA/BS or equivalent qualification. • Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications. Postgraduate training/certification /fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.). Experience • Preferred: Thorough understanding of local / international regulations applicable to clinical trials(pre and post approval). Practical experience in clinical trial strategies, methods and processes. Track record of design, oversight and interpretation of clinical studies. Previous leadership /management experience or training. • Required: Knowledge and experience in Good Clinical Practices. Experience in conduct and execution of clinical trials, including operational feasibility, recruitment, investigator performance, investigative site relations.
- 其他信息
- 语言要求：普通话
- 行业要求：医药外包,制药
公司简介
缔脉生物医药科技（上海）有限公司是一家临床合同研究组织（CRO），旨在为中国及全球生物医药公司和医疗器械公司提供高水准全方位的服务，包括为客户就临床开发的各个方面及产品注册申报出谋划策，也提供与临床试验相关的各种支持。致力于提高研发产品的成功率。
dMed Biopharmaceutical Company Limited is a clinical Contract Research Organization (CRO), providing high-end services to innovative biopharmaceutical and medical device companies. dMed is committed to increasing the probability of success of R&D products. Its services include Consulting, Clinical Operations, Biostatistics & Programming, Data Management, Pharmacovigilance, Clinical Science & Medical Affairs, Quality Assurance, Regulatory Affairs & Strategy.
我们的团队Our Team
• 团队管理成员全部来自全球一流生物医药企业,或跨国临床研究外包服务企业的高级管理人员
From executive and management team of global ******* biopharmaceutical companies or multinational Contract Research Organizations
•在各期临床试验及各类疾病领域拥有广泛经验，熟悉中国，美国，欧盟，日本等各地临床试验法规
Expertise in various therapeutic areas and all phases of clinical trials, familiar with clinical trial regulations in China, US, EU, Japan and other markets
• 拥有高度责任感为客户服务，值得信赖的专业团队
Trustworthy and Professional team with strong sense of accountability to serve our clients
服务对象及主营业务Our Clients and Services
• Provide service for domestic biopharmaceutical and medical device companies and small and medium-sized biopharmaceutical and medical device companies interested in China market End-to-End Services including Clinical Trial design and conduct, clinical trial data Analysis and Report, Regulatory submission, Systems support, Functional Services, comprehensive Consultation Services
• Provide service for multinational biopharmaceutical and medical device companies (In China for China & In China for Global), such as Statistics, Data Management, Programming, Medical Writing, Pharmacovigilance and Risk Management, Regulatory documentation support and operations, Quality Assurance & Audit
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