Sr. Manager, Risk-Based Quality Management

Moderna Therapeutics • Cambridge, MA

102d • Hybrid

About The Position

The Sr. Manager, Risk-Based Quality Management (RBQM) plays a critical cross-functional role in ensuring the quality and compliance of clinical trial execution through effective monitoring oversight and risk-based strategies. This role is responsible for overseeing site monitoring activities and co-monitoring efforts, as well as contributing to centralized monitoring, quality trend analysis, and risk mitigation initiatives. This individual may serve as the regional monitoring oversight lead for assigned programs, supporting internal teams and CROs in aligning operational execution with risk and quality expectations throughout the clinical trial lifecycle.

Requirements

• Bachelor's degree required in life sciences, healthcare, or related field or equivalent work experience required; Advanced degree preferred.
• A minimum of 7 years of clinical research, clinical operations or related experience, including at least 2 years of independent trial management, RBQM, or monitoring oversight experience.
• Working knowledge of GCP, regulatory guidelines, and quality risk management practices.
• Familiarity with CTMS, EDC, and centralized monitoring platforms.
• Effective communication and organizational skills with a strong attention to detail.
• Ability to travel up to 20%.

Responsibilities

• Support execution of RBQM strategies by contributing to study-level risk assessments and tracking mitigation activities.
• Monitor centralized risk data using tools and dashboards; escalate risk signals or operational trends for action planning.
• Assist in applying Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and Key Performance Indicators (KPIs) across studies.
• Serve as the regional or program-level point of contact for monitoring oversight, ensuring timely execution of co-monitoring visits, documentation, and reporting.
• Review monitoring reports and issue logs, providing guidance or retraining to CRO teams as needed.
• Conduct on-site or remote oversight visits and support site performance evaluation activities.
• Contribute to the development and implementation of Monitoring Oversight Plans, Clinical Monitoring Plans, and Vendor Oversight documentation.
• Identify performance or compliance trends and collaborate with clinical teams to implement corrective actions and quality improvement measures.
• Collaborate with Clinical Operations, Data Management, R D Quality, and CROs to ensure alignment between operational practices and RBQM principles.
• Assist with training and onboarding efforts related to RBQM tools and methodologies and monitoring oversight.
• Support the evaluation of new tools and dashboards that enhance centralized monitoring capabilities.
• Track and report quality trends, site- and study-level risks, and operational findings to inform process improvements.
• Provide documentation and data during audits, inspections, and internal reviews, and assist study teams with follow-up actions.
• Contribute to fostering a quality- and compliance-oriented culture across study teams.

Benefits

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs.
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
• Lifestyle Spending Accounts to personalize your well-being journey.
• Family planning and adoption benefits.
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment opportunities.
• Location-specific perks and extras.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree