Manager, Risk Based Quality Management

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

📋 Description

• Assist in the execution, operationalization, sustainability, and ongoing enhancement of CTI’s Risk-Based Quality Management framework across the clinical trial portfolio.

• Oversee the creation and upkeep of Integrated Quality and Risk Management Plans (IQRMPs).

• Aid and coordinate RACT, RMP, and IDRP activities, including protocol evaluations and assessments.

• Organize cross-functional risk review meetings and ensure action items are tracked to completion.

• Maintain documentation related to RBQM, including trackers, logs, templates, and SharePoint resources.

• Coordinate trial-specific RBQM initiatives and ensure accountability within the trial team.

• Support routine centralized monitoring, which includes KRI/QTL review activities and preparation for risk reviews.

• Collaborate with Clinical Project Management, Data Management, Quality, Medical Monitoring, Biostatistics, and other functional teams.

• Assist the Director of RBQM with strategic, operational, and client-facing initiatives.

• Utilize BI RBQM tools, CluePoints, Medidata, and other platforms for monitoring and documentation purposes.

• Contribute to initiatives aimed at improving processes related to RBQM execution, tools, and documentation.

⛳️ Requirements

• A Bachelor’s degree in health, life sciences, or a related field, or a comparable combination of education and experience.

• A minimum of 2 years of experience in clinical research, data management, monitoring, quality, or a similar role within a CRO, pharmaceutical, or healthcare environment.

• Basic knowledge of clinical trial operations and Good Clinical Practice (GCP).

• Experience with RBQM concepts, including Key Risk Indicators (KRIs), risk assessments, or centralized monitoring.

• Familiarity with ICH E6(R2/R3) guidelines.

• Experience using clinical trial systems, including EDC and RBQM tools such as CluePoints or Medidata.

• Previous experience in supporting risk review processes, data review, or quality oversight activities.

• Experience in reviewing clinical data, reports, or study metrics is preferred.

🏝️ Benefits

• Structured mentoring program.

• Leadership courses.

• Tuition reimbursement.

• Dedicated training department.

• Generous health benefits.

• Vacation packages.

• Hybrid work from home opportunities.

• Paid parental leave.

• CTI Cares program.

• Work-life balance support.