Risk-Based Quality Management Consultant - Remote

About us

Southern Star Research is a full-service Contract Research Organization (CRO) dedicated to navigating the complexities of bringing new medical products to market. With a legacy of excellence that began 14 years ago in Sydney, we have grown from a small, passionate team into a global network of experts committed to delivering high-quality services in medical writing, clinical monitoring, project management, biostatistics, data management, safety and medical monitoring, and quality assurance.

Southern Star Research has been recognized for its outstanding contributions to the field, winning prestigious awards such as the Frost and Sullivan 2024 Asia-Pacific Competitive Strategy Leadership Award and being named as Great Place to Work in Australia in 2024, 2025 and 2026. Our international team continues to deliver innovative clinical trial solutions across diverse therapeutic areas, ensuring the success of every study we manage.

The role

We are looking for an experienced Risk-Based Quality Management (RBQM) Consultant to provide expert guidance in developing and refining our internal RBQM processes, with a focus on small to mid-sized clinical studies.

Key Responsibilities:

• Conduct a gap analysis of our proposed RBQM processes and recommend practical improvements.
• Provide expert, experience-based advice on essential RBQM requirements and best practices.
• Support project teams during the initial stages of study delivery.
• Provide clear, practical recommendations and direction to support implementation.
• Assist with project management and coordination of the RBQM initiative.

Engagement Details:

• Short-term consulting opportunity for approximately 2–3 months.
• Up to 20 hours per week, with availability required before the end of 2026.
• Potential for ongoing ad hoc advisory support.

We are looking for a consultant with strong practical RBQM experience within clinical research, who can provide pragmatic, scalable solutions tailored to smaller and mid-sized studies.

Company Overview

Southern Star Research is trusted CRO offering world-class, high quality full-service clinical trails across the Asia Pacific region.