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Novatrials
Clinical Trial Unit Manager (Phase I)Novatrials • Newcastle, AU
Clinical Trial Unit Manager (Phase I)

Clinical Trial Unit Manager (Phase I)

Novatrials • Newcastle, AU
4 days ago
Job description

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.
  • Strong 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) • Newcastle, AU

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