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The Manager of RBQM supports the execution of risk-based approaches in clinical trial quality management to ensure patient safety and data integrity. Key duties include managing risk assessments, executing centralized monitoring activities, and providing monitoring oversight in collaboration with CROs.
Requires a bachelor's degree in life sciences or a related field and at least 6 years of experience in clinical research, including 1 year in RBQM or centralized monitoring. Candidates must have working knowledge of GCP and ICH guidelines and proficiency with clinical systems.
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.
Risk Management Support
Support 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 Execution
Participate 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 Support
Collaborate 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 Culture
Support 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%.
At 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.
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.
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.
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.
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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Our mission is to deliver the greatest possible impact to people through mRNA medicines.
Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn. This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762). Please be cautious of fraudulent recruitment offers claiming to be from Moderna. Recruitment scams of this sort may originate from fake websites, social media accounts, or unsolicited communications and may ask you for personal information or request you pay them or someone else. Moderna will never ask you for payment, banking information, or anything of this sort at any stage of the recruitment process. If you are unsure about a communication, do not provide personal information and report the activity to [email protected]. You may also report suspected fraud to the FBI’s Internet Crime Complaint Center (IC3).
Offices: 200 Technology Sq, Cambridge, Massachusetts 02139, US · 1 Upland Rd, Norwood, Massachusetts 02062, US
