Clinical Quality Operations Manager- Remote

Job Description It is critical that consistent, accurate, high-quality data is generated and maintained from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the CQOM is responsible for the execution of clinical quality oversight activities within an assigned trial. This includes proactive quality management, risk-based quality oversight, and clinical trial inspection management activities. The CQOM will provide clinical quality operations support to Trial Teams (TTs) to proactively embed quality into sponsored trials, ensure robust supplier oversight, and address critical quality issues as needed. The incumbent will assist with the overall strategy for maintaining ongoing inspection readiness, as well as preparing for, managing, and following up on regulatory inspections. Core Responsibilities: Trial Team, Research Portfolio and Enterprise Support Independently support assigned Trial Teams (TT) and drive implementation of Quality by Design. Act as a Process Subject Matter Expert (SME) within Clinical Quality Operations, providing guidance on quality processes, standards, and regulatory requirements to TTs. Support identification, investigation, escalation, and resolution of study-level quality issues including Significant Quality Issues (SQIs) and Serious Breaches (SBs). Support Trial Teams in assessing trial health and conducting quality reviews, as needed. Lead Inspection Hypercare Teams (IHT) with the