RBQM Risk & Quality Manager

RXinsider LTD.; Cambridge, Northern (MA, KY); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare

Well-being programs

Family planning benefits

Paid time off

Equity programs

Job summary

Moderna seeks a Manager, Risk-Based Quality Management to lead RBQM execution and drive continuous improvement in risk-based quality approaches across trials. You will work cross-functionally to ensure patient safety, data integrity, and regulatory compliance through RBQM principles including risk management and central monitoring.

You will partner with study teams, CROs, and Quality functions to ensure timely RBQM activities, develop plans, review CSR sections, and support documentation.

Qualifications

• Bachelor’s degree or equivalent required; life sciences background preferred.
• Minimum 6 years in clinical research or related field with RBQM exposure.
• Working knowledge of GCP, ICH E6(R2)/R3, and regulatory guidelines.
• Experience with clinical systems (CTMS, EDC, risk tools) and analytics.

Responsibilities

• Support risk management activities across study and program levels, including CTQ factors and QTLs.
• Assist in developing and maintaining the Integrated Quality Risk Management Plan (IQRMP).
• Contribute to CSR sections related to Risk Management and QTLs with traceability.
• Maintain QTL definitions, parameters, and thresholds documentation.
• Participate in monitoring oversight activities and data quality checks.

Skills

RBQM

Risk management

Data analysis

Communication

GCP knowledge

Education

Bachelor's degree or equivalent

Life sciences background preferred

Tools

CTMS

EDC

Centralized monitoring platforms

Risk assessment tools

Job description

Moderna seeks a Manager, Risk-Based Quality Management to lead RBQM execution and drive continuous improvement in risk-based quality approaches across trials. You will work cross-functionally to ensure patient safety, data integrity, and regulatory compliance through RBQM principles including risk management and central monitoring.

You will partner with study teams, CROs, and Quality functions to ensure timely RBQM activities, develop plans, review CSR sections, and support documentation.