Novatrials is a leading private clinical trial centre dedicated to bringing new treatments and medical innovations to the Newcastle community. Since 2018, we have successfully delivered Phase I-IV clinical trials across a broad range of therapeutic areas, providing participants with access to cutting-edge therapies while supporting the advancement of medical science.

As we continue to expand our Phase I capabilities, we are seeking an experienced and motivated Phase I Unit Manager to lead our growing team and help shape the future of early-phase clinical research at Novatrials.

About the Role

Reporting to the Chief Operating Officer, the Phase I Unit Manager will provide leadership and operational oversight of the Phase I Unit, ensuring the safe, efficient, and compliant conduct of clinical trials. You will work closely with investigators, coordinators, research nurses, pharmacists, laboratory staff and sponsors to deliver high-quality clinical research while fostering a positive and high-performing team culture.

This is a hands-on leadership role that combines team management, participant care, operational planning and clinical trial coordination.

Key Responsibilities

- Lead and mentor Clinical Trial Coordinators, Clinical Trial Assistants and other Phase I Unit staff.
- Manage staffing, rostering and resource allocation during participant confinement periods.
- Oversee day-to-day Phase I Unit operations, ensuring appropriate skill mix and clinical coverage across all shifts.
- Support the conduct of Phase I clinical trials in accordance with protocol requirements, ICH-GCP and applicable regulatory requirements.
- Drive operational excellence through continuous improvement of processes, systems and workflows.
- Manage Phase I Unit vendors, supplies and essential service providers.




- Support study planning, workload management and team development.
- Collaborate with investigators, sponsors, CROs and internal stakeholders to ensure successful study delivery.
- Maintain oversight of clinical trial management systems, quality systems and study data processes.
- Participate in study activities including participant assessments, ECGs, venepuncture and sample processing where required.

About You

You are an experienced clinical research professional with strong leadership capabilities and a passion for delivering exceptional participant experiences.

You will ideally possess:

- Tertiary qualifications in Nursing, Science, Allied Health, Pharmacy, Public Health or a related discipline.
- Proven experience coordinating and managing clinical trials.
- Previous leadership or people management experience.
- Robust knowledge of ICH-GCP, Australian clinical trial regulations and research governance requirements.
- Demonstrated experience in participant-facing clinical research environments.
- Excellent organisational, communication and stakeholder management skills.
- Experience with electronic clinical trial management systems, including RealTime and quality management platforms.
- Competency in venepuncture, IV cannulation and ECG procedures.
- A commitment to continuous improvement, participant safety and team development.

Why Join Novatrials?

- Opportunity to lead a growing Phase I Unit.
- Work with a passionate and collaborative multidisciplinary team.
- Contribute to cutting-edge clinical research that changes lives.
- Supportive leadership team focused on innovation and continuous improvement.
- Professional development and career growth opportunities.
- Be part of a values-driven organisation committed to excellence, integrity, respect and teamwork.

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📌 Clinical Trial Unit Manager (Phase I) (New South Wales)
🏢 Novatrials
📍 New South Wales