The Nurse Unit Manager – Clinical Trials is responsible for the operational, clinical, and people leadership of a Clinical Trials Unit. The role ensures the safe, compliant, and efficient delivery of Phase I-IV clinical research studies across a broad range of therapeutic areas while maintaining the highest standards of patient care, Good Clinical Practice (GCP), regulatory compliance, and sponsor satisfaction.

The Unit Manager provides leadership to Clinical Research Coordinators, Research Nurses, Clinical Trial Assistants, and other research personnel, ensuring the unit achieves recruitment, quality, financial, and operational objectives. The role acts as a key liaison between investigators, sponsors, CROs, ethics committees, and internal stakeholders.

KEY RESPONSIBILITIES

Clinical Operations & Trial Delivery

- Oversee the day-to-day operations of the Clinical Trials Unit.
- Ensure clinical trials are conducted in accordance with study protocols, ICH-GCP guidelines, ethical requirements, and applicable regulations.
- Monitor study progress, recruitment performance, participant retention, and protocol compliance.
- Support feasibility assessments and study start-up activities.
- Ensure timely completion of study milestones and achievement of enrolment targets.
- Identify operational risks and implement mitigation strategies.
- Drive continuous improvement initiatives to optimize trial conduct and participant experience.

Leadership & People Management

- Lead, mentor, and develop a multidisciplinary clinical trials team.
- Manage staffing requirements, workload allocation, and resource planning.
- Conduct performance reviews and support professional development activities.
- Foster a culture of collaboration, accountability, quality, and patient-centric care.
- Support recruitment, onboarding, and retention of clinical research staff.

Participant Care & Clinical Oversight

- Ensure participants receive high-quality, safe,



and ethical care throughout trial participation.
- Support clinical staff in the management of study visits, assessments, and participant engagement.
- Oversee participant safety reporting processes, including adverse events and serious adverse events.
- Escalate safety concerns appropriately to investigators, sponsors, and relevant stakeholders.

Quality & Compliance

- Maintain inspection and audit readiness at all times.
- Ensure adherence to SOPs, GCP, privacy legislation, and institutional policies.
- Lead responses to sponsor audits, regulatory inspections, and quality reviews.
- Oversee CAPA implementation and quality improvement initiatives.
- Ensure accurate and complete trial documentation, regulatory files, and essential records.

Stakeholder Management

- Build strong relationships with Sponsors, CROs, Investigators, and industry partners.
- Serve as the primary operational contact for external stakeholders.
- Participate in business development discussions and sponsor meetings.
- Collaborate with laboratory, pharmacy, finance, ethics, and clinical departments to support study delivery.

QUALIFCATIONS & EXPERIENCE

- Bachelor's degree in Nursing, Health Science, Biomedical Science, Pharmacy, Life Sciences, or related discipline.
- Registration as a Registered Nurse (if clinically qualified) desirable.
- Minimum 5 years' experience within clinical research operations.
- Previous leadership or management experience within a clinical trials environment.
- Solid knowledge of ICH-GCP, TGA regulations, and National Statement on Ethical Conduct in Human Research.
- Demonstrated experience managing multiple concurrent clinical studies.
- Proven ability to lead and develop high-performing teams.

SALARY

LOCATION

Newcastle / Greater Sydney area

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

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📌 Nurse Unit Manager - Clinical Trials (New South Wales)
🏢 Planet Pharma
📍 New South Wales