Job Description

Project Management: Develop and maintain project management plans; conduct project management covering schedule, quality, cost, risk, training and communication. Take charge of archiving and management of research‑related materials and process documents.

Operational Management: Ensure timely completion of trial initiation, execution and close‑out for assigned projects in compliance with GCP and relevant regulatory requirements.

Project Training: Deliver training on pre‑marketing study protocols and procedures for CRAs, CRCs, investigators and other relevant stakeholders.

Project Monitoring: Conduct monitoring activities for pre‑marketing clinical studies to ensure trials are performed in accordance with study protocols, SOPs and applicable regulations.

Project Communication: Coordinate relationships among site principal investigators, study physicians, auxiliary departments, clinical trial institutions and research teams to facilitate smooth project delivery. Organize and host investigator meetings and project progress reviews on a regular basis. Report trial progress and quality status periodically; identify, analyze and resolve issues with actionable solutions.

Job Requirements

Bachelor’s degree or above, major in Medicine, Clinical Medicine, Public Health or other related disciplines.

Minimum 5 years of hands‑on clinical trial experience. Prior experience in pre‑marketing clinical trials is preferred; experience with innovative drug clinical trials is highly preferred.

In‑depth knowledge of clinical trial workflows and relevant regulatory requirements; proficient in professional medical English.

Excellent communication, crisis‑response and problem‑solving skills with high emotional intelligence.

Proven team‑leadership experience; strong organizational, coordination and project‑planning capabilities.

Willing to travel for work.