Primary Function :
Quality and Compliance Management in clinical product development.

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, 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 judgment 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.