Roles and Responsibilities: The Sr. Specialist, Clinical Affairs will be responsible for managing the clinical studies, including feasibility study, clinical trial and post-market study. 61 Identifying study needs and objectives in collaboration with global clinical affairs, clinical development, RA, marketing and GA teams; 61 Engaging the KOLs as the potential investigators; 61 Preparing study documents for Ethical Committee submitting, HGRAC review, etc.; 61 Managing the timeline and resources of clinical studies to ensure the delivery of data and results promptly; 61 Conducting monitors with CRA of CRO; 61 Responsible for the maintenance of the Trial Master File (TMF), collecting and tracking the Investigator-Site File (ISF); 61 Responsible for AE reporting; 61 Managing the CRO and SMO project teams; 61 Other responsibilities related to the operation of clinical studies. Competency Requirements: 61 3+ years of experiences in clinical trial operation and project management; experience in medical device trials preferred; 61 Proved capability of clinical study operation, data analysis and clinical study report (CSR) drafting; experience in real-world study and HTA study is a plus; 61 B.A. / B.S. degree in medicine or life science required, graduate degree preferred; 61 Demonstrated ability to work across departmentally as well as with external parties; 61 Excellent oral and written communication skills in English; 61 Strong interpersonal skills; 61 Self-motivated and proactive working attitude.
