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).