This is an 0ne-year contractor role.

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.