Sr. Manager, Risk-Based Quality Management

The Role :

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.

Here's What You'll Do :

RBQM Execution Support

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.

Monitoring Oversight Coordination

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.

Cross-Functional Support

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.

Quality Monitoring & Improvement

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.

Here's What You'll Need :

Required Education, Experience, Certifications :

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%.

At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• 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

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com / careers to learn more about our current opportunities.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70 / 30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and / or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

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