Senior Manager, Clinical Quality Assurance

Job description

Job Description The Senior Manager, Clinical Quality Assurance is responsible for the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by Deciphera. The primary responsibilities are to ensure both quality and compliance of Deciphera sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices. Key Responsibilities: Clinical Quality Support 50%: - Draft, review or revise Clinical QA SOPs to assess consistency and compliance with regulatory requirements/internal standards - Attend cross-functional team meetings and provide guidance to clinical operations staff based on interpretation of current regulations to ensure best practices including risk-based management - Work closely with Clinical Operations to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary - Provide Quality Control (QC) review of clinical protocols, amen...