Responsibilities
Primarily responsible for the conduct of internal, vendor andinvestigator site audits as assigned by management. Otherresponsibilities include:

 Perform audits of complex clinical documents, computer systems,various clinical vendors and investigator sites
 Ensures audits are scheduled and conducted per audit schedules
 Writes audit reports in English and ensures complete information isincluded so it can be understood by operational teams and senior management
 Responsible to participate Investigator Site Audits.
 Escalates potential critical/major issues to management in a timely fashion
 Point of contact for Contract Auditors, for any audits which need tobe outsourced.
 Writes audit reports in a timely fashion, according to SOP requirements.
 Meets with operational teams to ensure understanding of the risksassociated with the findings following the audit.
 Ensures corrective/preventive actions meet regulatory expectations andare followed to closure.
 Supports the development and maintenance of SOPs, forms and templatesto maintain a consistent and compliant QMS.
 Assists with training sessions to ensure continued qualification andunderstanding of topics relevant to clinical trials.
 Supports Third-Party Audits and Regulatory Inspections.
 Participate in process improvement projects and/or other projectsidentified by management.



Qualifications:
 Bachelor’s degree, or equivalent is required.
 Candidate will have 8 years of Clinical Trial experience within aclinical quality role.
 Written and spoken English proficiency is required.
 Must be willing and able to travel internationally up to 40%.
 Must be fluent in written and spoken Chinese, native speaker preferred(Chinese Auditor positions only).