The Medical Operations Manager provides clinical and operational leadership across the Medical Department to ensure delivery of safe, high‑quality medical services within early‑phase clinical trials. The role oversees Medical Officers, supports study conduct as PI/Sub‑I, ensures compliance with ICH‑GCP and NN SOPs, and collaborates closely with cross‑functional teams to optimise participant safety, operational efficiency, and study outcomes.

Key Responsibilities

1. Clinical Leadership & Participant Safety

- Oversee clinical care delivered to participants, ensuring all medical assessments and procedures meet protocol, GCP, and regulatory requirements.
- Review, evaluate, and appropriately escape adverse events and safety concerns to ensure participant wellbeing.
- Serve as Principal Investigator or Sub‑Investigator as required, providing expert clinical oversight during study conduct.
- Ensure readiness for audits and inspections through consistent, high‑quality documentation and compliance practices.

2. Medical Team Supervision & Capability Building

- Lead, mentor, and support Medical Officers and contracted doctors to ensure consistent, high‑quality practice.
- Oversee medical rostering, resource allocation, and competency management aligned to study load and site requirements.
- Provide ongoing coaching, supervision, and performance input in line with NN values and clinical expectations.
- Support onboarding and training of new Medical Officers, ensuring they are equipped to operate safely and confidently within NN’s early‑phase environment.

3.



Study Delivery & Cross‑Functional Collaboration

- Provide medical insight to study feasibility, protocol interpretation, and operational strategy.
- Collaborate closely with Clinical Operations, Project Management, Recruitment, Laboratory, Pharmacy, and Quality teams to ensure seamless study execution.
- Contribute to preparation and review of study‑related documents (e.g., SFSD, medical procedures, safety plans).
- Participate in investigator meetings, protocol briefings, and internal study start‑up activities.

4. Governance, Quality & Compliance

- Ensure all medical activities comply with ICH‑GCP, NN SOPs, TGA, ethics requirements, and global regulatory standards.
- Engage in continuous quality improvement, identifying risks or gaps and implementing corrective actions.
- Support deviation assessments, CAPA development, and quality reviews as needed.
- Contribute to policy and SOP development to strengthen medical governance frameworks.

Key Requirements

- Medical degree and current AHPRA registration
- Experience in clinical trials or acute/critical care medicine; early‑phase experience highly valued.
- Strong working knowledge of ICH‑GCP, ethical requirements, and clinical trial regulatory frameworks.
- Demonstrated clinical leadership ability and confidence supervising medical staff.
- Strong decision‑making, problem‑solving, and communication skills with a cooperative mindset.
- Commitment to participant safety, clinical excellence, and NN’s values of Care, Collaboration, and Innovation.

#J-18808-Ljbffr

📌 Medical Operations Manager (Melbourne)
🏢 Nucleus Network
📍 Melbourne