Clinical Research Physician(ONCO)/肿瘤领域临床研究医师

    • Shanghai, China

Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18
Posted Date: Mar 31 2020

Provide medical input into clinical studies involving China

  • Develop appropriate protocol synopsis and protocols to support research proposals and meet local registration need
  • Actively participate feasibilities at program, protocol and site level for global/regional studies, and provide timely and quality feedback
  • Perform medical monitoring for the studies in charge
  • Assist with study operation team in coordinate with Investigator and leading site selection
  • Prepare and deliver presentations for product and protocol introduction at investigator meetings and trainings to study team
  • Act as protocol and clinical lead in a study team, approve protocol deviations, analyze AEs/SAEs, and answer clinical and product queries from investigators
  • Provide valuable inputs in statistical analysis plan finalization and efforts in achieving batabase clean
  • Prepare and finalize local clinical study report, and assist study result publication

Provide medical support to deliver regulatory submissions(IND and NDA, etc)
  • Relevant medical document preparation
  • Support communication with regulatory agency(including panel meetings, etc) and relevant material preparation

Ensure governance across all clinical activities
  • Ensure a high level of self directed understanding, dissemination and teaching of the GSK policies and SOPs
  • Ensure the safe and ethical conduct of trials
  • Medical governance of activities before asset launch in China under scientific engagement principles

Perform as project leader to be accountable for China development strategy for early stage compound in Specialty Care.

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