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 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%.
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 needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investments to help you plan for the future
- Location-specific perks and extras
The 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.
