RBQM Leader - Risk-Based Quality Management

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

Benefits offered by this job

Healthcare benefits

Well-being resources

PTO & holidays

Location-specific perks

Job summary

Moderna is seeking a Manager, Risk-Based Quality Management (RBQM) to drive risk-based quality initiatives in clinical trials, ensuring patient safety, data integrity, and regulatory compliance. The role partners with study teams, CROs, and Quality functions to implement RBQM principles across risk management, central monitoring, and monitoring oversight.

The position emphasizes cross-functional collaboration, preparation for inspections, and continuous quality improvement within a hybrid

Qualifications

• Bachelor’s degree or equivalent work experience; degree in life sciences, healthcare, or related field preferred.
• 6+ years of experience in clinical research or related field, with RBQM exposure.
• Working knowledge of GCP, ICH E6(R2)/R3, and regulatory guidelines.

Responsibilities

• Support risk management, central monitoring, and monitoring oversight activities.
• Contribute to IQRMP, CSR sections, QTLs, KRIs, and traceability documentation.
• Assist in central monitoring setup, validation of KRIs/QTLs, SDV plans, and data quality checks.
• Collaborate with cross-functional teams to drive quality-by-design initiatives and audit readiness.

Skills

RBQM

Risk management

Central monitoring

GCP

Regulatory knowledge

Communication

Travel up to 20%

Education

Bachelor’s degree or equivalent

Life sciences degree preferred

Tools

CluePoints

CTMS

EDC

Job description

Moderna is seeking a Manager, Risk-Based Quality Management (RBQM) to drive risk-based quality initiatives in clinical trials, ensuring patient safety, data integrity, and regulatory compliance. The role partners with study teams, CROs, and Quality functions to implement RBQM principles across risk management, central monitoring, and monitoring oversight.

The position emphasizes cross-functional collaboration, preparation for inspections, and continuous quality improvement within a hybrid