Clinical Development Scientist(IGT)
You are responsible for
According to Clinical Evaluation process and regulations, guidelines
- Participate in the evidence generation processes for New Product introduction & Life-Cycle Management.
- Participate in the CDMA(Clinical Development and Market Access) process, develop clinical and health economic evidence to support market authorization, market access and market adoption.
- Participate in the development of clinical deliverables, including clinical evaluation plans and reports, clinical trial protocols and reports, PMCF plans and reports & clinical sections of regulatory submissions.
- Work closely with Clin Ops and BS&DM on day to day management of assigned clinical studies.
- Support clinical literature searches and reviews.
You will base inBeijing/Shanghai/Shenzhen.
To succeed in this role, you should have the following skills and experience
- Education: Master or PhD in clinical medicine or Biomedical Engineering;
- Experience: More than 5 years’ experience in clinical development function or related clinical area;
- Competencies and Skills:
Demonstrated expertise in NMPA and/or MDR regulatory requirements and clinical data interpretation;
Effective organizing, communication, and project management skills;
ffective verbal and written skills in both English and Mandarin;
Proficient in Biostatistics software is preferred.