PRIMARY FUNCTION

Act as principal link between the investigator and HMP for trial management, esp. on-site monitoring

MAJOR RESPONSIBILITIES AND DUTIES

Site management for assigned trial

Be familiar with trial execution process of assigned trial

Be responsible for following activities:

• Site selection
• Prepare Site specific documents include but not limit to EC presentation slide, GCP office require documents, Inform Consent, study contract, site drug management manual, subject management matrix etc.
• Site initiation
• Site monitoring based on applicable monitor plan
• Site close out visit
• Key personnel to coordinate with trial specific vendors to complete the trial related activities.
• Complete all trial related report within SOP defined timeline

• Site master file and investigator file management
• Deliver trial related training to site staffs
• Update site status to project manager at timely manner
• Prepare all required report to line manager at timely manner

Qualifications

• At least 2 year clinical trial on site management experience
• At least bachelor degree in Clinical Medicine or Pharmacy or related major
• Good communication skill and team player
• Good command of computer skill
• Adequate verbal and written communication skills in English

Internal-External Relations

Internal: staffs within C&R department

External: Investigators and other relevant persons in hospitals or institutes

上班地址：张江高科技园区哈雷路917弄4号楼