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上海, 北京, 臨床及註冊 | 2021-09-30

Associate Director/Director, Clinical QC head

Job Title: Associate Director/Director, Clinical QC head
Department/Group: Clinical and Regulatory Affairs
Location: Beijing / Shanghai

 

Primary Duties

  • Quality and Compliance Management in clinical product development.
  • SOP and quality management system set up
  • Lead inspection readiness for NDA studies
  • Organize related training

 

Responsibilities

  • Hutch-med related SOP set up and maintenance
  • Implement and deliver the agreed upon Quality Control plan which includes risk management, The scope of QC should be including all C&R functions
  • Assist Clinical and Regulatory department to deliver a better compliance with relevant ICH GCP, GCP, country regulations and guidelines.
  • Provide advice and support to Clinical Operations, Medical Science including Project Managers and other key stakeholders with regard to quality control, risk assessment and management, and corrective actions.
  • QC activities including selected system checking, TMF review and co-monitoring activities.
  • Lead the site inspection preparation and deal with the inspection with other functions
  • Support QA activities.
  • Coordinate internal and external resource to provide related training for C&R staffs

 

Qualifications

  • At least bachelor degree in a health care or other scientific discipline. Clinical Medicine or pharmacy is preferred.
  • At least 10 years’ industry experience with proven proficiency in clinical research management for drug development.
  • Monitoring experience or equivalent combination of education, training and experience.
  • Sound knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, CFDA/FDA/EMEA/PMDA regulation and quality.
  • Knowledge of CRO or Pharmaceutical industry operations.
  • Good organizational, interpersonal and communication skills.
  • Good judgement and decision-making skills.
  • Strong influencing and negotiation skills and excellent problem solving skills.
  • Demonstrated ability to work in a matrix environment.
  • Proficiency in English (written and oral) and familiarity with standard IT office tools.

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