Clinical Trial Unit Manager - Phase I Clinical Trials
Clinical Trial Unit Manager - Phase I Clinical Trials
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 Novatrials
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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