16 Aug
|
Perth Blood Institute
|
Western Australia
16 Aug
Perth Blood Institute
Western Australia
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.
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 productive, 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 ****)
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.
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📌 Clinical Trials Operations Manager (Western Australia)
🏢 Perth Blood Institute
📍 Western Australia