Clinical Project Manager临床PM

Shanghai, China
Full Time
Pharma
Manager/Supervisor

A large pharmaceutical company is seeking for the right talent to join their Shanghai, China office. The company focuses on the development, production, and commercialization of mAb biosimilar drugs, bio-betters and novel mAbs using cutting-edge technology. Additional, the company have so far invested over 400 million RMB in the early development of monoclonal antibody drugs. Products currently in development cover a variety of therapeutic areas including oncology and autoimmune diseases.

Job Responsibilities

  • Provide oversight of clinical trial to ensure clinical trials follow the procedure and policies
  • Forecast, track, and monitor clinical study progress (i.e., Regulation, SOP, ICH-GCP)
  • Effectively collaborate with and manage stakeholders throughout the organization in order to ensure successful completion of clinical study activities. 
  • Development timelines, and execute consistent with those timelines, for study start-up activities

Qualifications 

  • BS/BA degree or higher in biological science, pharmacy or equivalent.
  • 2 years experience in Clinical Project management 

工作职责

  • 临床试验项目管理
  • 监督和全面管理所有临床研究项目，以确保：临床试验进程符合既定要求，并保证临床试验的操作符合国家相关法规及公司SOP要求
  • 保障临床试验项目按照试验方案、项目管理计划书和监查计划的要求顺利执行
  • 少部分临床试验监查

临床监查

  • 按照公司SOP、ICH-GCP的要求，对所负责临床试验项目进行及时有效的实施、执行和临床监查工作

岗位要求

  • 临床医学、药学本科及以上学历
  • 临床项目管理工作经验2年以上
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