RBQM Manager: Risk-Based Quality Leader

BioSpace; Cambridge (MA); On-site; USD 109,000 - 175,000; Full time

Job summary

Moderna is seeking a Manager, Risk-Based Quality Management (RBQM) to lead risk-based quality programs in clinical trials, ensuring patient safety, data integrity, and regulatory compliance through RBQM, risk management, central monitoring, and monitoring oversight. This role collaborates cross-functionally to implement RBQM across studies.

The position involves risk assessments, KRIs, QTLs, IQRMP, CSR contributions, setup of centralized monitoring systems, SDV plans, data quality reviews, and

Qualifications

• Bachelor’s degree or equivalent work experience; life sciences, healthcare, or related field preferred.
• 6+ years in clinical research or related field, with 1+ year RBQM exposure.
• GCP, ICH E6(R2)/R3 knowledge and regulatory guidelines.
• Experience with clinical systems (CTMS, EDC, risk tools, centralized monitoring).
• Strong organizational, analytical, and communication skills.
• Proficiency with Microsoft Office (Excel).
• Ability to travel up to 20%.

Responsibilities

• Support study- and program-level risk assessments, CTQ factors, QTLs, KRIs, and mitigation tracking.
• 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 documentation for QTL definitions, parameters, and thresholds.
• Participate in setup and review of centralized monitoring activities and reports.
• Contribute to central monitoring plans, programming specs, and SDV plans.
• Perform data quality checks, support UAT, and assist with data review and trend analysis.
• Support investigation and documentation of risk signals, trends, and actions.
• Collaborate with clinical and vendor teams to align RBQM strategies and oversight.
• Assist in Monitoring Oversight Plans and monitor metrics and issue trends.
• Review CRO and site monitoring reports and oversight documentation.
• Contribute to corrective or preventive actions and training initiatives.

Skills

RBQM principles

Risk management

Central monitoring

Quality management

Communication skills

Analytical skills

Travel up to 20%

Education

Bachelor's degree or equivalent

Life sciences/healthcare degree preferred

Tools

Microsoft Office (Excel)

CTMS / EDC systems

Job description

Moderna is seeking a Manager, Risk-Based Quality Management (RBQM) to lead risk-based quality programs in clinical trials, ensuring patient safety, data integrity, and regulatory compliance through RBQM, risk management, central monitoring, and monitoring oversight. This role collaborates cross-functionally to implement RBQM across studies.

The position involves risk assessments, KRIs, QTLs, IQRMP, CSR contributions, setup of centralized monitoring systems, SDV plans, data quality reviews, and