A fast-growing clinical research organisation is seeking an experienced Laboratory Manager to lead its Clinical Trials Laboratory function supporting early-phase clinical studies.
This is a pivotal leadership role responsible for ensuring operational excellence, regulatory compliance, and the delivery of high-quality laboratory outcomes in a fast-paced, highly regulated environment.
In this position, you will oversee all laboratory operations supporting early-phase clinical trials. You'll ensure the laboratory operates to the highest standards of GCP, IATA, and OH&S compliance, while maintaining audit readiness, data integrity, and participant safety.
You will also play a key role in building and leading a high-performing team and ensuring laboratory readiness for complex clinical studies.
We are looking for a proactive and detail-oriented leader with strong experience in clinical trial laboratory environments. You bring a passion for quality, operational excellence, and team development.
Responsibilities
* Lead end-to-end clinical trial laboratory operations, including sample handling, processing, storage, and shipment
* Ensure compliance with regulatory frameworks (GCP, ALCOA+, OH&S) and trial-specific requirements
* Maintain audit-ready systems and lead internal and external audit activities
* Oversee laboratory resourcing, capacity planning, and study start-up readiness
* Monitor performance metrics and implement continuous improvement initiatives
* Provide clear and consistent operational and quality reporting
* Lead, mentor, and develop a high-performing laboratory team
* Collaborate with internal stakeholders and external partners to ensure seamless study delivery
Skills and experience required
* Tertiary qualifications in Science (or related discipline)
* ~5+ years of laboratory experience
* ~3+ years of experience in clinical trials
* Demonstrated leadership or team management experience
* Strong knowledge of GCP and clinical trial laboratory operations
* Experience managing audits, CAPAs, and quality systems
* Excellent communication and stakeholder management skills
* Must be a citizen/PR of Australia/New Zealand
What's on offer
* Opportunity to lead within a high-performing clinical research environment
* Exposure to complex early-phase clinical studies
* A collaborative, supportive, and professional team culture
* The chance to drive continuous improvement and operational excellence
* Career progression within a fast-growing organisation
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