Job title: Clinical PM
Reporting line: Clinical Operation Project Director
Location: Base in Shanghai
Identify, select, initiate and close-out investigational sites for clinical studies in phases I – III independently to ensure applicable regulations and principles of ICG-GCP are adhered to.
Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation.
Submission of protocol, consent documents for ethics/IRB approval.
Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required.
Managing data manager generated queries efficiently and responsible for study cost effectiveness.
Dependent on level of experience you may assist in training and mentoring less experienced CRA’s and/or manage CRA’s working on international projects.
Accompany visit and Quality control visit for site, on-site inspection support.
Oversight outsourced project CRA work.
Maintain good relationship with KOL and GCP officer.
Experience & Qualification
2 years+of monitoring experience in phase I~IV trials as a CPM.
Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data.
Conversational English at least.
Excellent communication and interpersonal skills.
Ability to produce accurate work to tight deadlines within a pressurized environment.
50% domestic or international travel may be requested.
Please send your resume to firstname.lastname@example.org, and look forward to joining us.