JOB FUNCTION: Clinical Operation and Innovation
GRADE/TITLE: Clinical Trial Supervisor
EMPLOYER: Brii Biosciences (腾盛博药)
DEPARTMENT: Clinical Development
JOB LOCATION: Beijing, China
REPORTS TO: Head, Clinical Operation and Innovation
SUMMARY: The CTS is accountable for supporting execution of clinical trials.
DUTIES AND RESPONSIBILITIES:
Provide technical support and administrative support to study teams and Clinical Development China department.
Participate in or lead preparation of vendor(s) selection; support or lead vendor(s) management activities throughout the course of study.
Participate in the development of study plans and systems set-up.
Implement or design appropriate tools to ensure quality oversight on any vendor(s).
Participate in or lead study budget forecast based on study timeline and be responsible for study budget tracking, vendor’s invoices checking and payment application.
Support study team to maintain study documents to ensure the quality of the (e)TMF in compliance with ICH-GCP, applicable regulatory requirement and Brii SOPs.
Organize study-related meetings including investigator meetings, study team meetings, and any ad-hoc meetings. Support study team with meeting agenda, meeting materials and meeting minutes.
Coordinate or lead the study newsletter design.
Support any study audits and inspections.
Support or lead HGRAC application.
Participate in or lead the procedures set up in Clinical Operation function and coordinate relevant trainings.
Conduct relevant trainings to Clinical Trial Assistant in conjunction with the head of Clinical Operation and Innovation.
Education (minimum/desirable): Bachelor degree or above
Languages: Fluent Chinese and English both in spoken and written
At least 5-year experience in clinical development function
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.