Director, Clinical Trial Quality – Risk Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Design, implement, and continuously enhance the NCCT clinical quality management strategy.

• Develop and operationalize risk-based quality management (RBQM) frameworks throughout clinical trial activities.

• Define and uphold risk assessment methodologies to proactively identify and mitigate operational and compliance risks.

• Establish standardized quality control processes integrated within clinical trial workflows.

• Ensure uniform application of quality practices across various sites, studies, and functional teams.

• Develop and supervise centralized statistical monitoring programs to detect data anomalies, trends, and potential quality risks.

• Establish key quality indicators (KQIs) and dashboards to track performance across clinical trials.

• Provide NCCT leadership with real-time visibility into quality trends, risks, and performance gaps.

• Oversee quality control activities across clinical trial processes to guarantee compliance with SOPs and protocol requirements.

• Identify, monitor, and analyze 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 applicable.

⛳️ Requirements

• Bachelor's degree in life sciences, healthcare, or a related field is required.

• Over 7 years of experience in clinical research, quality management, or related roles within healthcare or life sciences.

• Proven experience in clinical quality management, risk-based monitoring, or centralized monitoring.

• Familiarity with working in regulated environments (e.g., FDA, ICH-GCP).

• Experience in navigating complex, matrixed organizations.

• Background in collaborating with regulatory, compliance, or audit functions within a healthcare or research context.

• Strong understanding of clinical trial operations, Good Clinical Practice (GCP), and regulatory requirements.

• Experience in designing and implementing risk-based quality management (RBQM) frameworks.

• Proficiency in centralized monitoring and data-driven quality methodologies.

🏝️ Benefits

• Paid Time Off programs.

• Health and welfare benefits including 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 matching and other financial wellness programs.

• Educational Assistance Program.