職位描述
Description：The Clinical Affairs Supervisor/Manager offers key support to medical product registration in China: •Develop clinical strategy together with RA personnel•Drive the clinical related activities•Ensure clinical activities in compliance with regulatory requirements and company standards.Education：A Master/Bachelors Degree in clinical medicine. Experience：3-5 years working experience in the medical/clinical field preferred as the following:-1-2 years working experience as a medical doctor (eye doctor or intern is a big plus) in hospitals. -2-3 years of working experience of clinical affairs (CA) in medical device company.Other skills：Experienced with running clinical trials, analyzing and documenting clinical results.Considerable English language level (listening, reading, writing and spoken).Solid problem-solving and project management skills.Good teamwork and ability to work cross-functionally.Good communication skill. Ability to interact professionally in the medical environment.Basic statistical skills consistent with needs of position.Willing to travel if necessary.Directly superior position to：N/APrinciple Responsibilities：?Develop clinical strategy by working closely with local and global regulatory affairs (RA) and CA team.?Drive the clinical studies Write up clinical evaluation reports for the applicable products for RA submission. Develop clinical protocols if clinical study is required.Plan, perform, and manage off-site and on-site clinical studies.Compile, analyze, and report results of clinical trials. Release study documents including investigator's data, protocol, CRF (clinical record form), informed consent forms, and study report, etc.May be involved in the global multi-center study?Develop the clinical-related process as needed?Provide technical support to marketing personnel from the clinical perspective ?Maintain knowledge of the guidelines for Good Clinical Research Practices and of Ethics Committee pro-cedures if applicable. ?Apply advanced understanding of CFDA regulations and international standards under which clinical studies of medical devices are conducted.?Other duties, as assigned.
