Clinical Research Manager

Responsibilities：

• Communicate with client while whole trial life to gain support and experiences to facilitate of clinical studies. Organize and or coordinate clinical studies and oversee progress and quality
• Organize and or coordinate study initiation including protocol/CRF/ICF/diary card development, PSV, PI/site selection, CRO training
• Organize investigator meetings and trainings, oversee all related preparation including administrative issues such as material printing, labeling & packaging and other logistic affairs
• Develop and maintain good working relationship with KOLs and related PIs.
• Prepare Investigator Package Plan and training for CRO and or CRAs
• Review and approve EC submission to IRBs, and IP for each site for drug release
• Monitor and guide CRO and or CRAs to ensure the study progress and quality
• Coordinate with CRO and or CRAs to follow up the audit findings
• Support medical writing of study protocol and clinical study report
• Support regulatory submission to SFDA on clinical overview/reports
• Support sales/marketing/BD departments’ on medical opinion
• Manage clinical team and giving proper training according to SOPs

Required：

• Master degree or above prefer on medical.
• At least 5 years’ experience in clinical trials including site management, project management and etc.
• Familiar with ICH and Chinese GCP and related guidelines.
• Result oriented.
• Customer focus and teamwork.
• Organizational commitment.
• Good communication skill.
• Good at English writing and speaking