Job Title: RBQM Business Analyst
Location: Remote
Job Summary:
The RBQM (Risk-Based Quality Management) Business Analyst will serve as a bridge between business stakeholders, clinical operations teams, and technology groups to design, implement, and enhance RBQM processes and systems within clinical development programs. The ideal candidate will have strong knowledge of RBQM methodologies, clinical trial operations, data analytics, and regulatory requirements (ICH E6 R2/R3).
Key Responsibilities:
· Collaborate with Clinical Operations, Data Management, and Quality teams to define and refine RBQM processes and workflows.
· Gather, document, and translate business requirements into functional specifications for RBQM tools and systems.
· Support the implementation of RBQM platforms (such as CluePoints, Medidata Detect, or similar systems).
· Analyze key risk indicators (KRIs), quality tolerance limits (QTLs), and central monitoring data to identify study-level and site-level risks.
· Partner with data scientists and analytics teams to develop dashboards and reports supporting ongoing risk assessments.
· Ensure alignment of RBQM practices with regulatory and GCP standards.
· Participate in user acceptance testing (UAT), validation, and change management for RBQM tools.
· Support training, documentation, and continuous improvement of RBQM frameworks.
· Communicate insights and recommendations to stakeholders through reports and presentations.