RBQM Manager: Quality Risk & Central Monitoring

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

Benefits offered by this job

Healthcare benefits

Mental health support

Family planning benefits

Paid time off

Savings plan

Location-specific perks

Job summary

Moderna is seeking a Manager of Risk-Based Quality Management (RBQM) to lead risk assessment, KRIs, QTLs, and integrated quality plans in clinical trials. You will collaborate with study teams, CROs, and Quality to ensure patient safety, data integrity, and regulatory compliance through RBQM principles.

This role involves central monitoring execution, data quality checks, UAT support, and ongoing process improvements. A strong background in RBQM and applicable systems is required.

Qualifications

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

Responsibilities

• Support study- and program-level risk assessments and mitigation tracking.
• Develop and maintain the Integrated Quality Risk Management Plan.
• Contribute to CSR sections on Risk Management and QTLs with traceability.
• Maintain QTL definitions, parameters, and thresholds.
• Assist setup and review of centralized monitoring activities and KRIs.
• Contribute to monitoring plans, programming specs, and SDV plans.
• Perform data quality checks and support UAT and trend analysis.
• Assist investigations of risk signals and actions.
• Collaborate with teams to align RBQM strategies and oversight.
• Help maintain Monitoring Oversight Plans and track metrics.
• Review CRO/site monitoring reports and issue logs.
• Identify performance or compliance trends and support CAPAs.
• Support training and process improvement; maintain inspection readiness.
• Partner with cross-functional teams to promote quality-by-design.

Skills

RBQM

Cross-functional collaboration

Analytical skills

Microsoft Excel

Communication skills

Travel flexibility

Education

Bachelor’s degree or equivalent in life sciences/healthcare

Tools

CTMS

EDC

Centralized monitoring tools

CluePoints

Job description

Moderna is seeking a Manager of Risk-Based Quality Management (RBQM) to lead risk assessment, KRIs, QTLs, and integrated quality plans in clinical trials. You will collaborate with study teams, CROs, and Quality to ensure patient safety, data integrity, and regulatory compliance through RBQM principles.

This role involves central monitoring execution, data quality checks, UAT support, and ongoing process improvements. A strong background in RBQM and applicable systems is required.