Quality and Compliance Management in clinical product development.
- 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.
- 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.