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中國其他地區, 临床开发, 北京, 臨床及註冊 | 2022-01-25

Associate Quality Control Manager

Job Title: Clinical Project Manager
Location: Shanghai/Guangzhou

 

Primary Function

  • Quality and Compliance Management in clinical product development.

Major Responsibilities and Duties

  • Implement and deliver the agreed upon Quality Control plan which includes risk management.
  • Assist Clinical Operations to deliver a better compliance with relevant ICH, GCP, country regulations and guidelines.
  • Contribute to the development of and responsible for implementation and delivery of specific initiatives as defined and agreed upon.
  • 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 MVR review, TMF review and co-monitoring activities.
  • Support QA activities.

Qualifications

  • At least bachelor degree in a health care or other scientific discipline. Clinical Medicine or pharmacy is preferred.
  • At least 3 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 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 KellyL@hutch-med.com