崗位職責: 1. As the CRA to conduct the site QC, ensure the site’s quality GCP compliance. 2. Support PM to manage Menarini sponsored PK, BE, phaseIII studies, assist to oversight study vendors to ensure successful conduction of assigned study activities to agreed budget, timeline, quality & compliance TMF filing. 3. Oversee Investigational Products clinical supplies management. 4. Manage all study essential documents to be collected archived timely. 5. Coordinate track external vendmilestone payment. 6. Manage the company supported ISS(investigator-sponsored study), closely track study progress, budget supplies. Ensure study management in compliance with GCP, SOP regulation. Negotiate with internal external stakeholders to ensure the whole process going smoothly raise the issues in time. 7. Collaborate with cross-functional department such as Regulatory Affair, Sales & Marketing, IT, Finance Legal to support project milestone achievement. 8. May support other assigned functional activities if needed. 任職要求: 1. Bacheldegree in a health care discipline, clinical medicine pharmacy 2. At least 3-4 years of clinical operation experience, have basic knowledge of all phases fthe drug development process, phase I studies medical device experiences are preferred. 3. Familiar with clinical trial SOPs, GCP, CFDA regulations 4. Good self-learning, problem-solving, communication, execution 5. Fluent in English, familiar with the excel, office, PPT