临床项目经理

Responsibility for Project Manager
Ensure that the clinical studies are performed according to existing laws and regulations (ICH-GCP, CFDA-GCP).
Ensure that studies are performed according to CCBR standard procedures and quality regulations.
Plan, implement and drive all aspects of clinical studies in compliance with GCP.
Ensure that the clinical studies are performed according to the protocols.
Ensure that patient data is handled according to the national Data Protection law, if any.
Ensure that project tasks conform with the scope of the project and any signed agreements between CCBR and clients.
Develop and maintain close working relationship with BD to ensure clients satisfaction, operational and customer service excellence.
Lead the project team to fulfill the project requirements and meet the client’s need .
Ensure that all staff involved in study have received the relevant training and new information before and during the study procedures.
Proactively communicate the status of ongoing projects, issues, and risks that may affect the clinical trial and project schedule with internal team.
Communicate reglularly with investigator sites and vendors to ensure smooth study set up and maintain exceptional study conduct, review site performance, and identify and be aware of site/study issues.
Conduct motivational visits, as well as, develop materials and initiatives to support patient recruitment and retention with each site.
Acts as main contact for study sites and sponsors and provide answers to study and device-related questions.
Ensure management is well informed on project progression and revenue tracking.