Risk Based Quality Management (RBQM) Specialist

Job Title: Risk Based Quality Management (RBQM) Specialist


Location: REMOTE


Type: Contract


Compensation: $75 an hour W2


Contractor Work Model: Remote


Hours: 40.0

Overview

Responsibilities

• Support clinical trial teams in designing, monitoring, and executing RBQM strategies across studies from startup through closeout.
• Lead development of Risk Assessment & Mitigation Plans, including Critical-to-Quality (CtQ) factors, Key Risk Indicators (KRIs), PQTLs, and monitoring strategies.
• Perform centralized monitoring and identify trends or quality signals to ensure data integrity and trial quality.
• Partner with Clinical Trial Teams (CTTs) to drive mitigation actions addressing identified risks.
• Collaborate with CROs/vendors on RBQM implementation and oversight processes.
• Review protocols for risk identification and contribute to quality-by-design initiatives.
• Support RBQM documentation, tools, templates, and SOP alignment efforts.
• Train stakeholders on RBQM methodologies, best practices, and system tools.
• Contribute to continuous improvement initiatives and cross-study learnings to enhance risk management practices.

Requirements

• Bachelor's degree with 8+ years of experience in biotech/pharma industries.
• Strong experience with RBQM frameworks and execution in clinical trials.
• Support experience with CTTs including risk assessments, monitoring plans, and mitigation strategies.
• Hands-on experience with KRIs, PQTLs, and centralized monitoring systems.
• Familiarity with clinical trial operations or data management processes.
• Knowledge of ICH-GCP (E6 R3, E8 R1) guidelines.
• Experience working with CROs and external vendors.
• Strong analytical, organizational, and communication skills.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific