Manager, RBQM

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.

Responsibilities

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); 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); Perform data quality checks, support User Acceptance Testing (UAT), and assist with initial data review and trend analysis; Collaborate with clinical and vendor teams to support execution of monitoring oversight activities in alignment with RBQM strategies; Assist in review of CRO and site monitoring reports, issue logs, and oversight documentation; Support training initiatives and contribute to process improvement efforts related to RBQM; Maintain documentation to ensure inspection readiness and contribute to audit preparation activities

Requirements

Bachelor’s degree or equivalent work experience required; 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%

Nice to have

Degree in life sciences, healthcare, or related field (preferred)

Benefits

Competitive healthcare; Voluntary benefit programs; 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 discretionary year-end shutdown; Savings and investments; Location-specific perks and extras; Eligibility for annual discretionary bonus, other incentive compensation, or equity award