Director, Clinical Trial Quality – Risk Management

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Advocate Aurora Health

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

💰 $10.2M Grant on 2019-08

Healthcare Insurance

Advocate Aurora Health is a leading healthcare organization that operates across various regions including Central Chicagoland, Central Wisconsin, Greater Milwaukee, and more. With a diverse range of career areas such as advanced practice clinicians, behavioral health, nursing, and more, Advocate Aurora Health is committed to helping people live well. The organization offers numerous benefits and opportunities for career advancement, fostering an environment where individuals can thrive and innovate in the healthcare sector. Advocate Aurora Health prioritizes the safety of its candidates and maintains a robust recruitment process to protect sensitive information.

📋 Description

• Design, implement, and continuously refine the NCCT clinical quality management approach • Develop and operationalize risk-based quality management (RBQM) frameworks across clinical trial activities • Define and maintain risk assessment methodologies to proactively identify and mitigate operational and compliance risks • Establish standardized quality control processes embedded within clinical trial workflows • Ensure consistent application of quality practices across sites, studies, and functional teams • Develop and oversee centralized statistical monitoring programs to identify data anomalies, trends, and potential quality risks • Establish key quality indicators (KQIs) and dashboards to monitor performance across clinical trials • Provide real-time visibility into quality trends, risks, and performance gaps to NCCT leadership • Oversee quality control activities across clinical trial processes to ensure adherence to SOPs and protocol requirements • Identify, track, and trend deviations, issues, and quality events across studies and sites • Coordinate root cause analysis and corrective and preventive actions (CAPAs) in collaboration with functional teams and enterprise QA as appropriate

🎯 Requirements

• Bachelor’s degree in life sciences, healthcare, or a related field required • 7+ years of experience in clinical research, quality management, or related roles within healthcare or life sciences • Demonstrated experience in clinical quality management, risk-based monitoring, or centralized monitoring • Experience operating within regulated environments (e.g., FDA, ICH-GCP) • Experience working within complex, matrixed organizations • Experience collaborating with regulatory, compliance, or audit functions in a healthcare or research setting • Strong knowledge of clinical trial operations, GCP, and regulatory requirements • Experience designing and implementing risk-based quality management (RBQM) frameworks • Proficiency in centralized monitoring and data-driven quality approaches

🏖️ Benefits

• Paid Time Off programs • Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability • Flexible Spending Accounts for eligible health care and dependent care expenses • Family benefits such as adoption assistance and paid parental leave • Defined contribution retirement plans with employer match and other financial wellness programs • Educational Assistance Program