NSW | Clinical Research | Leadership Opportunity A growing clinical research organisation is seeking an experienced Phase I Unit Manager to lead the operational delivery and expansion of its early-phase clinical trials unit.
Key Responsibilities
- Lead, mentor and develop a multidisciplinary Phase I clinical research team.
- Oversee day-to-day unit operations, staffing, rostering and resource planning.
- Ensure Phase I studies are delivered safely, efficiently and in compliance with ICH-GCP and regulatory requirements.
- Partner with investigators, sponsors, CROs and internal stakeholders to drive successful study execution.
- Optimise processes, systems and workflows to support operational excellence and future growth.
- Support participant-facing study activities, including clinical procedures where required.
Requirements
- Degree in Nursing, Science, Pharmacy, Allied Health, Public Health or a related discipline.
- Proven experience managing and coordinating clinical trials.
- Previous people leadership experience within a clinical research setting.
- Strong knowledge of ICH-GCP, Australian clinical trial regulations and research governance.
- Excellent stakeholder management, communication and organisational skills.
- Experience with CTMS and quality management systems preferred.
- Competency in venepuncture, cannulation and ECGs advantageous.
Ideal Background
- Clinical Operations professional with exposure to early-phase studies.
- Experience within CROs, site networks, Phase I units, hospitals or independent research centres.
Opportunity Play a key role in building and scaling a growing Phase I research capability, leading high-performing teams and contributing to the delivery of cutting-edge clinical trials from first-in-human through to later-stage development.