Clinical Trials Manager

On Q Recruitment; Sydney; Hybrid; AUD 120,000 - 150,000; Full time

Job summary

On Q Recruitment partners with an Australian biotechnology organisation to recruit a hands-on Clinical Trials Manager. You will lead operational delivery of a Phase III trial across Australia, focusing on site engagement, recruitment performance and vendor oversight.

Based in Sydney with hybrid work (3 days in the SYD office, 2 days work from home), you will report to the Head of Clinical Operations and collaborate with Asia-Pacific partners to ensure GCP compliance, inspection readiness and

Qualifications

• Senior clinical trials professional with Phase III experience.
• Strong site monitoring and management skills.
• Solid knowledge of ICH-GCP and regulatory requirements in Australia.

Responsibilities

• Drive operational delivery of an active clinical trial.
• Conduct site monitoring visits and maintain strong site engagement.
• Monitor recruitment performance and implement strategies to support enrolment targets.
• Oversee local partners, CROs, vendors and service providers.
• Ensure compliance with GCP, study protocols and regulatory requirements.
• Maintain study documentation, trial management systems and inspection readiness.

Skills

Site management

Monitoring

ICH-GCP knowledge

Vendor oversight

Phase III experience

Job description

On Q are proud to partner with an innovative Australian biotechnology organisation developing breakthrough therapies designed to address serious global health challenges. With an active Phase III clinical trial currently underway, we are seeking a hands-on Clinical Trials Manager to lead operational delivery across Australia and support activities in Asia-Pacific.


This is an exciting opportunity to join a lean, agile team where you will have direct visibility across all aspects of trial execution and the ability to make a genuine impact on study outcomes.


The Opportunity
Reporting to the Head of Clinical Operations, you will be responsible for overseeing the day-to-day management of a Phase III clinical trial in Australia, including site engagement, recruitment performance, monitoring activities and vendor oversight. You will also support the coordination and oversight of local partners and sites in the Asia-Pacific region.

Key Responsibilities

• Drive operational delivery of an active clinical trial
• Conduct site monitoring visits and maintain strong site engagement
• Monitor recruitment performance and implement strategies to support enrolment targets
• Oversee local partners, CROs, vendors and service providers
• Ensure compliance with GCP, study protocols and regulatory requirements
• Maintain study documentation, trial management systems and inspection readiness

This role will suit a proactive, self-sufficient clinical professional who enjoys remaining close to sites and operational delivery rather than managing large teams.


About You
To be successful, you will bring:

• Solid years' experience within Clinical Research as a Senior CRA, Clinical Trials Manager, Clinical Project Manager or similar role
• Experience supporting or managing late-stage and/or Phase III clinical trials
• Strong site management and monitoring experience
• Strong knowledge of ICH-GCP and Australian clinical trial requirements
• Experience overseeing CROs, vendors and external partners
• Experience within biotech, startup or emerging pharmaceutical environments is advantageous

What's on Offer?

• Broad exposure across trial management, site engagement and international operations
• Opportunity to work directly with senior leadership
• Hybrid working environment (3 in SYD office / 2 WFH)
• Travel to investigator sites within Australia and periodic Asia-Pacific travel (approx. every two months, dependent on trial requirements)

If you're seeking an opportunity to join an innovative and growing biotechnology environment, we'd love to hear from you.