Manager, RBQM

The Role: The Manager, Risk-Based Quality Management (RBQM) supports the execution and continuous improvement of risk-based approaches in clinical trial quality management. This role works cross-functionally to help ensure patient safety, data integrity, and compliance through effective implementation of RBQM principles, including risk management, central monitoring, and monitoring oversight.The Manager partners closely with study teams, CROs, and Quality functions to ensure RBQM activities are conducted according to defined processes, timelines, and regulatory expectations.Here’s What You’ll Be Doing:Risk Management SupportSupport study- and program-level risk assessments, including identification of Critical to Quality (CTQ) factors, development of Quality Tolerance Limits (QTLs) and Key Risk Indicators (KRIs), and tracking of mitigation actions.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. Central Monitoring ExecutionParticipate in setup and review of centralized monitoring activities, including configuration and validation of KRIs, QTLs, and related reports in monitoring systems (e.g., CluePoints).Contribute to central monitoring plans, programming specifications, and SDV plans.Perform data quality checks, support User Acceptance Testing (UAT), and assist with initial data review and trend analysis.Support investigation and documentation of potential risk signals, trends, and associated actions.Monitoring Oversight SupportCollaborate with clinical and vendor teams to support execution of monitoring oversight activities in alignment with RBQM strategies.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 implementation of corrective or preventive actions.Continuous Improvement and Quality CultureSupport training initiatives and contribute to process improvement efforts 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.Here’s What You’ll Need (Basic Qualifications):Bachelor’s degree or equivalent work experience required; degree in life sciences, healthcare, or a related field preferred.A minimum of 6 years of experience in clinical research, clinical operations or related field, including at least 1 year of exposure to risk management, centralized monitoring, or 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%.Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Competitive healthcare, plus voluntary benefit programs to support your unique needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportFamily planning benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investments to help you plan for the futureLocation-specific perks and extrasThe salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.About ModernaSince 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. Equal OpportunitiesModerna 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. AccommodationsWe’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 View email address on click.appcast.io. 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. -SummaryLocation: Cambridge, Massachusetts; Clinical DevelopmentType: Full time