Responsibilities：
· 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, including Project Managers and other key stakeholders with regard to quality control, risk assessment and management, and corrective actions.
· QC activities including on site QC and TMF review activities.
· Support inspection activities.
Qualifications：
· At least bachelor degree in a health care or other scientific discipline. Clinical Medicine or pharmacy is preferred.
· At least 3 years quality 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.