General Summary

l Conduct QCSV to assist the assigned operational staff in improving compliance with relevant ICH-GCP, SOPs, applicable regulatory requirements and guidelines.

l Contributes to site quality issue resolution.

l Provides advice and support to relevant key stakeholders with regards to quality control and corrective/preventive actions

Accountabilities

l Provides advice and support to operational teams including Clinical Research Associates, Line Managers and other key stakeholders on all aspects of GCP compliance.

l Preparation for the QCSV, including communication with study team, review site TMF documents, hold Pre-visit meeting.

l Conducting on-site QCSV and Issue Escalation.

l Follow up the QCSV, including hold post-visit meeting, complete QCSV report, support Root Cause Analysis and CAPA completion.

l Works in close cooperation with operational staff to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.

l Supporting on Quality Issues resolution.

l Developing And Delivering Lessons Learned (LL).

l Informs Quality Control Manager, Head of Clinical Operations and line management of Operational staff and Quality Assurance of quality issues according to SOPs.

l May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with the Head of Clinical Operations and as required by the applicable SOPs.

l Acts as the primary contact between Quality Control Manager and Project team and Clinical Operations on clinical quality matters-on the level of the assignment, attend meetings/teleconferences.

l Works closely with Quality Assurance and assigned business staff in case of suspected misconduct as required by the applicable SOPs.

l Performs any other reasonable tasks as required by the role.

l May assume a customer (site or sponsor) facing role to the extent required by the assignment and applicable SOPs.

Qualifications

l Bachelor's degree in life sciences or equivalent nursing qualification with a minimum of 5 years’ experience in Clinical Monitoring, preferably including experience in a role equivalent to GCP auditor/QC specialist experience is preferred, Lead CRA/Clinical Team Lead; or equivalent combination of education, training and experience

l Knowledge of National and International Regulations and Drug Development processes

l Knowledge of CRO or Pharmaceutical industry operations

l Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers

l Excellent verbal and written communication skills, interpersonal skills

l Excellent organizational skills

l Fluent in English

上班地址：马当路388号SOHO复兴广场A座