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Clinical Operations and Regulatory Affairs, Shanghai | 4 Oct 2021

Clinical Research Physician

Job Title: Clinical Research Physician
Location: Shanghai

 

Responsibilities

  • Support medical director in drafting clinical trial protocol and study report.
  • Contribute to  the  medical/scientific  input  given  for  the  development  of  trial-related documents such as IB, ICF etc. and processes which reside in other line functions.
  • Establish and maintain liaisons with investigators.
  • Serve as back-up medical monitor to provide medical support to trial sites and clinical operation team.
  • Support regulatory filing where medical expertise is required.
  • Support drug discovery when clinical experience is needed for the medical “translation”.
  • Lead clinical trial data review and generate clinical queries, quality control and data validation for clinical study reports, publications and internal/external presentations.
  • Prepare and conduct regular meetings with investigators.
  • Support clinical study site and CRO selection in trial conduct and clinical trial outsourcing process.
  • Support the  regional clinical  strategy for  a  project  through  Clinical  development, in partnership with relevant matrix team members.
  • Compliance with GCP, SOP and regulatory requirements.
  • Study planning, preparation, conduct and report in terms of timeline, quality and quantity
  • Other tasks as assigned.

 

Requirements

  • Graduate from Clinical Medicine with bachelor degree or above.
  • At least 3-5 year clinical practice / clinical development / clinical research experience. Therapeutic area experience esp. oncology or hematology. Working experience with international pharmaceutical company or CRO is preferable.
  • GCP experience is preferred.
  • Proficiency in English and good computer skill at office software.
  • Excellent planning, organization and problem solving abilities.
  • Good communication and interpersonal skills.
  • Good project management skill.
  • Self-motivation and good risk management.

 
If interested, please forward your resume to winniew@hutch-med.com