临床项目经理

1.MSc in a scientific field (biology, pharmacy), Medical background preferred
2.3-5 years clinical research experience in the relevant industry, IVD industry with team management experience preferred
3.Good knowledge of clinical trial process and the process of sites
4.Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements, Chinese regulation preferred
5.Chinese native speaker with fluent English in both written and oral

1.Establish project plan with clear timeline and deliverables and ensure the implementation of the defined plan;
2.Responsible for plan and protocol writing, data controlling, data reporting, and final report writing and guiding junior CRAs;
3.Responsible for site selection, site qualification, site monitoring, site management, if necessary negotiate site contracts;
4.Responsible for CROs selection as required;
5.Coordinate complex studies at multiple sites potentially involving teams of CRA(Clinical Research Associate);
6.Prepare, conduct & monitor clinical trials, coordinate all contact with the sites, problem solving, analyzing data; lead problem solving & troubleshooting on technical issues;
7.Lead reviews of data periodically & keep Project Team informed;
8.Lead preparation of final trial reports & close the trial.