Phase I Unit Manager

NSW | Clinical Research | Leadership Chance 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 environment.
Robust 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 skilled 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.

📌 Clinical Trial Unit Manager Phi Newcastle
🏢 Planet Pharma
📍 Newcastle