Manager/Senior Manager, Clinical Quality Assurance

Hiring under Eisai Clinical Research Singapore Pte Ltd

Job Description

The Manager/Senior Manager, Clinical Quality Assurance , will plan, prepare, perform, and report on audits of clinical investigational sites and vendors for clinical studies in Asia Pacific. This person will also lead in health authority inspection activities in this region and provide GCP consultation to clinical study teams. These actions ensure that a high level of quality and compliance is maintained in clinical research activities.

Primary Responsibilities

Audits

• Accountable for the quality and integrity of assigned Audit Plans
• Prepares and conducts routine, complex and for-cause audits
• Authors and peer reviews audit reports
• Communicates audit outcome to vendors, clinical investigators and internal stakeholders
• Provide QA support and guidance to stakeholders in developing root cause analys...