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.

+ S...