Job Title

The Medical Operations Manager provides clinical and operational leadership across the Medical Department to ensure delivery of safe, highquality medical services within earlyphase clinical trials. The role oversees Medical Officers, supports study conduct as PI/SubI, ensures compliance with ICHGCP and NN SOPs, and collaborates closely with crossfunctional teams to optimise participant safety, operational efficiency, and study outcomes.Key Responsibilities1. Clinical Leadership & Participant SafetyOversee 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 SubInvestigator as required, providing expert clinical oversight during study conduct.Ensure readiness for audits and inspections through consistent, highquality documentation and compliance practices.2. Medical Team Supervision & Capability BuildingLead, mentor, and support Medical Officers and contracted doctors to ensure consistent, highquality 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 earlyphase environment.3. Study Delivery & CrossFunctional CollaborationProvide 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 studyrelated documents (e.g., SFSD, medical procedures, safety plans).Participate in investigator meetings, protocol briefings, and internal study startup activities.4. Governance, Quality & ComplianceEnsure all medical activities comply with ICHGCP, 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 RequirementsMedical degree and current AHPRA registrationExperience in clinical trials or acute/critical care medicine; earlyphase experience highly valued.Strong working knowledge of ICHGCP, ethical requirements, and clinical trial regulatory frameworks.Demonstrated clinical leadership ability and confidence supervising medical staff.Strong decisionmaking, problemsolving, and communication skills with a collaborative mindset.Commitment to participant safety, clinical excellence, and NN''s values of Care, Collaboration, and Innovation. #J-18808-Ljbffr