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.

  Internal-External Relations

  Internal: staffs in C&R department

  External: Investigators and other relevant persons in hospitals or institutes, business partner, CRO and other vendors

  
  

上班地址：张江高科技园区哈雷路917弄4号楼