Medical Manager
上海康德弘翼医学临床研究有限公司ShanghaiUpdate time: August 2,2019
Job Description
上海市 黄浦区
  • To provide medical monitor leadership to clinical development teams.
  • To contribute to medical monitor strategy for new drug and medical device products’ clinical development and registration.
  • To interact with inter-departmental and external consultants, investigators, and regulatory agencies as appropriate.
  • To contribute to trial design, develop, review and revise IND/CTA documents, protocols, IB, CRF, ICF, IRB/EC documents, SAP, CSR and NDA documents.
  • To participate and present in investigator meetings, steering committees, data monitoring committees meetings, adjudication committees, et al.
  • To conduct medical and safety monitoring, review clinical lab values, AEs, coding dictionaries and data tables, listings and figures.
  • To assist with data safety monitoring board activities.
  • To provide project-specific and therapeutic training to sponsors and company staff.

职能类别: 药品生产/质量管理

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