RBQM Quality Manager — Risk & Central Monitoring

Moderna; Cambridge (MA); On-site; USD 109,200 - 174,600; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking a Manager, Risk-Based Quality Management (RBQM) to drive the execution and continuous improvement of RBQM in clinical trials. You will partner with cross-functional teams to protect patient safety, data integrity, and regulatory compliance through risk management, central monitoring, and monitoring oversight.

Responsibilities include supporting risk assessments, developing QTLs and KRIs, configuring monitoring reports, and contributing to quality processes and training.

Qualifications

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

Responsibilities

• Support risk assessments, identify CTQ, QTLs, KRIs, and track mitigations.
• Assist in developing and maintaining the Integrated Quality Risk Management Plan (IQRMP).
• Contribute to CSR sections related to Risk Management and QTLs, ensuring traceability and documentation accuracy.
• Maintain documentation for QTL definitions, parameters, and thresholds.
• Configure and validate KRIs, QTLs, and reports in monitoring systems.
• Contribute to central monitoring plans, programming specifications, and SDV plans.
• Perform data quality checks, support UAT, and assist with initial data review and trend analysis.
• Support investigation and documentation of potential risk signals, trends, and associated actions.
• Collaborate with clinical and vendor teams to support monitoring oversight activities.
• Help maintain Monitoring Oversight Plans and track monitoring metrics and issue trends.
• Assist in review of CRO and site monitoring reports, issue logs, and oversight documentation.
• Contribute to identification of performance or compliance trends and support corrective/preventive actions.
• Support training initiatives and contribute to process improvement related to RBQM.
• Maintain documentation to ensure inspection readiness and contribute to audit preparation activities.
• Partner with cross-functional teams to reinforce a proactive, quality-by-design mindset.

Skills

GCP knowledge

ICH guidelines

Microsoft Office

Analytical skills

Communication skills

Travel up to 20%

Education

Bachelor’s degree or equivalent

Life sciences background preferred

Tools

CTMS

EDC

Risk assessment tools

Centralized monitoring platforms

Job description

Moderna is seeking a Manager, Risk-Based Quality Management (RBQM) to drive the execution and continuous improvement of RBQM in clinical trials. You will partner with cross-functional teams to protect patient safety, data integrity, and regulatory compliance through risk management, central monitoring, and monitoring oversight.

Responsibilities include supporting risk assessments, developing QTLs and KRIs, configuring monitoring reports, and contributing to quality processes and training.