Phase I Unit Lead — Clinical Trials Operations

Novatrials; Newcastle-Maitland; On-site; AUD 180,000 - 230,000; Full time

Benefits offered by this job

Lead Phase I Unit

Collaborative multidisciplinary team

Cutting-edge clinical research

Professional development

Job summary

Novatrials in Newcastle is seeking an experienced Phase I Unit Manager to lead our Phase I Unit and drive safe, compliant early-phase trials. You will collaborate with investigators, coordinators, nurses, pharmacists, labs and sponsors to deliver high-quality research and maintain a positive, high-performing team culture.

The role combines people leadership, operational planning and hands-on trial coordination across Phase I activities within a private clinical trial centre committed to

Qualifications

• Proven experience coordinating and managing clinical trials.
• Leadership or people management experience.
• Knowledge of ICH-GCP and Australian trial regulations.
• Experience with venepuncture, ECG and sample handling preferred.

Responsibilities

• Lead and mentor Phase I Unit staff.
• Manage staffing, rostering and resources.
• Oversee day-to-day Phase I Unit operations.
• Support conduct of Phase I trials per protocol and ICH-GCP.
• Drive continuous process improvements.
• Manage Phase I Unit vendors and essential service providers.
• Support study planning and team development.
• Collaborate with investigators, sponsors, CROs and stakeholders.
• Oversee trial management systems and data quality.
• Participate in participant assessments and sample handling when required.

Skills

Leadership

Project management

Communication

Stakeholder management

Organisational skills

Safety-minded/Participant safety

Education

Nursing or Allied Health degree

Tools

RealTime EDC

Quality management platforms

Job description

Novatrials in Newcastle is seeking an experienced Phase I Unit Manager to lead our Phase I Unit and drive safe, compliant early-phase trials. You will collaborate with investigators, coordinators, nurses, pharmacists, labs and sponsors to deliver high-quality research and maintain a positive, high-performing team culture.

The role combines people leadership, operational planning and hands-on trial coordination across Phase I activities within a private clinical trial centre committed to