Job Description
The Perth Blood Institute Established in ****, 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.
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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'll turn strategy into action, driving efficient trial delivery, strong compliance, and a high-performing team, while working closely with our General Manager - Clinical Research.
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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.
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About the Role
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Reporting to the General Manager - Clinical Research, and leading a team of up to 7, you'll be the operational backbone of the CTU. Day to day, you will:
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Oversee CTU operations, workflows, resourcing and service delivery
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Lead recruitment, onboarding, performance management and rostering for CTU staff
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Oversee delivery of active clinical trials, from start-up through to close-out
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Coordinate with the Research Team on investigator-initiated trials (IITs)
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Ensure compliance with ICH-GCP, regulatory and ethical requirements, and maintain CTU SOPs and quality systems
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Act as operational lead for the CTMS and eISF platforms, including training, access and vendor management
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Develop and track operational KPIs, dashboards and reporting
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Support budget development,
cost tracking and financial performance monitoring
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Oversee research database systems, ensuring data integrity, security and privacy compliance
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Provide executive support and coordination for the General Manager, Board Chair and senior leadership as required
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About You
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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.
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Essential requirements
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Tertiary qualification in Nursing, Health Sciences, Life Sciences or a related discipline, with substantial experience in clinical trials management
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Robust 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 ****)
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Excellent communication, organisational and IT skills (MS Word/Excel), with the ability to work independently and manage competing priorities
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High personal integrity and discretion, with confidence engaging participants, families, sponsors and multidisciplinary teams
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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
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Why Join PBI?
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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.
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📌 Clinical Trials Operations Manager (Perth)
🏢 @
📍 Perth