Clinical Trials Operations Manager

Perth Blood Institute; Perth; On-site; AUD 120,000 - 150,000; Full time

Job summary

The Perth Blood Institute is seeking an experienced Operations Manager to lead the Clinical Trials Unit (CTU) in Western Australia. You will translate strategy into action, ensure compliant trial delivery, and build a high-performing team.

Reporting to the General Manager - Clinical Research, you will oversee CTU operations, manage recruitment and rostering, support budget and reporting, and maintain data integrity across CTMS and eISF platforms.

Qualifications

• Tertiary qualification in Nursing, Health Sciences, Life Sciences or related discipline with clinical trials management experience.
• Strong knowledge of ICH-GCP E6(R3) and Australian regulatory/ethical frameworks.
• Excellent communication, organisational and IT skills with ability to manage priorities.
• High integrity and discretion with confidence engaging participants, sponsors and multidisciplinary teams.
• Desirable: experience in early-phase trials, project management, auditing or quality/risk management.

Responsibilities

• Oversee CTU operations, workflows, resourcing and service delivery.
• Lead recruitment, onboarding, performance management and rostering for CTU staff.
• Oversee delivery of active clinical trials, from start-up through to close-out.
• Coordinate with the Research Team on investigator-initiated trials (IITs).
• Ensure compliance with ICH-GCP, regulatory and ethical requirements, and maintain CTU SOPs and quality systems.
• Act as operational lead for the CTMS and eISF platforms, including training, access and vendor management.
• Develop and track operational KPIs, dashboards and reporting.
• Support budget development, cost tracking and financial performance monitoring.
• Oversee research database systems, ensuring data integrity, security and privacy compliance.
• Provide executive support and coordination for the General Manager, Board Chair and senior leadership as required.

Skills

People leadership

Regulatory knowledge

IT skills

Communication skills

Project coordination

Education

Tertiary qualification in Nursing/Health Sciences/Life Sciences

Tools

CTMS

eISF platforms

Regulatory management software

Job description

The Perth Blood Institute

Established in 2013, the Perth Blood Institute is one of the largest haematology research centres in Australia. The Perth Blood Institute is a not-for-profit research institute focused on delivering the highest possible standard of care for people diagnosed with blood disorders.

Lead operations at the heart of clinical research in WA.

Perth Blood Institute (PBI) is looking for an experienced Operations Manager to take charge of the day-to-day running of our Clinical Trials Unit (CTU). This is a pivotal leadership role where you will turn strategy into action, driving efficient trial delivery, strong compliance, and a high-performing team, while working closely with our General Manager - Clinical Research.

If you thrive on variety, enjoy leading people, and want your operational expertise to directly support life-changing clinical research, this role is for you.

About the Role

Reporting to the General Manager - Clinical Research, and leading a team of up to 7, you will be the operational backbone of the CTU. Day to day, you will:

• Oversee CTU operations, workflows, resourcing and service delivery


• Lead recruitment, onboarding, performance management and rostering for CTU staff


• Oversee delivery of active clinical trials, from start-up through to close-out


• Coordinate with the Research Team on investigator-initiated trials (IITs)


• Ensure compliance with ICH-GCP, regulatory and ethical requirements, and maintain CTU SOPs and quality systems


• Act as operational lead for the CTMS and eISF platforms, including training, access and vendor management


• Develop and track operational KPIs, dashboards and reporting


• Support budget development, cost tracking and financial performance monitoring


• Oversee research database systems, ensuring data integrity, security and privacy compliance


• Provide executive support and coordination for the General Manager, Board Chair and senior leadership as required

About You

You are an experienced clinical trials operations leader who combines strong people leadership, regulatory expertise and commercial acumen to deliver efficient, compliant and high-quality research outcomes.

Essential requirements:

• Tertiary qualification in Nursing, Health Sciences, Life Sciences or a related discipline, with substantial experience in clinical trials management


• Strong working knowledge of ICH-GCP E6(R3) and Australian regulatory/ethical frameworks (National Statement on Ethical Conduct in Human Research, Australian Code for Responsible Conduct of Research, Australian Clinical Trial Handbook, Therapeutic Goods Act 1989)


• Excellent communication, organisational and IT skills (MS Word/Excel), with the ability to work independently and manage competing priorities


• High personal integrity and discretion, with confidence engaging participants, families, sponsors and multidisciplinary teams


• Desirable: experience in early-phase trials, project management, auditing or quality/risk management within clinical trials or healthcare; prior experience within a site, CRO or pharmaceutical company

Why Join PBI?

Perth Blood Institute is committed to compassion, collaboration, agility, respect and excellence in everything we do. You'll be part of a values-driven organisation making a genuine impact on clinical research outcomes in Western Australia, with a leadership team that supports your professional growth.