Lead Clinical Excellence in Groundbreaking Early-Phase Research
As a Medical Operations Manager, you will provide the clinical and operational leadership essential for the safe and effective delivery of early-phase clinical trials. In this pivotal role, you will oversee a team of Medical Officers, serve as an Investigator, and ensure that every aspect of medical service meets the highest standards of quality, compliance, and patient safety. Your leadership will directly impact the integrity of our studies and the wellbeing of our participants, driving forward the development of novel therapies.
Your Key Responsibilities
Clinical Leadership & Participant Safety
- Oversee all clinical care provided to study participants, ensuring strict adherence to protocols, ICH-GCP, and regulatory standards.
- Review, evaluate, and appropriately escalate adverse events and safety concerns to safeguard participant wellbeing.
- Serve as Principal Investigator (PI) or Sub-Investigator (Sub-I) as required, providing expert medical oversight throughout study conduct.
- Ensure the site remains audit and inspection-ready through meticulous documentation and compliance practices.
Team Supervision & Professional Development
- Lead, mentor, and support a team of Medical Officers and contracted doctors, fostering a culture of clinical excellence and consistent practice.
- Manage medical rostering, resource allocation, and competency in alignment with study demands and site requirements.
- Provide ongoing coaching, performance feedback, and support the onboarding and training of new medical staff within the early-phase environment.
Study Delivery & Cross-Functional Collaboration
- Provide critical medical insight during study feasibility, protocol development, and operational planning.
- Collaborate seamlessly with Clinical Operations, Project Management, Recruitment, Laboratory, Pharmacy, and Quality teams to ensure efficient study execution.
- Contribute to the preparation and review of essential study documents, including Study Specific Procedure Documents (SFSD), medical procedures, and safety plans.
- Actively participate in investigator meetings, protocol briefings, and study start-up activities.
Governance, Quality & Compliance
- Ensure all medical activities comply with ICH-GCP, NN SOPs, TGA regulations, and global ethical standards.
- Drive continuous quality improvement by identifying risks, implementing corrective actions (CAPA), and supporting deviation management.
- Contribute to the development and refinement of medical policies and SOPs to strengthen governance and operational frameworks.
Your Profile: Key Requirements
- Medical degree with current, unrestricted registration with AHPRA.
- Substantial experience in clinical trials or acute/critical care medicine; experience in early-phase (Phase I) clinical research is highly valued.
- Strong, practical knowledge of ICH-GCP guidelines, ethical requirements, and clinical trial regulatory frameworks.
- Proven clinical leadership ability, with experience in supervising and mentoring medical staff.
- Excellent decision-making, problem-solving, and communication skills, with a collaborative and team-oriented mindset.
- A deep commitment to participant safety, clinical excellence, and organisational values of Care, Collaboration, and Innovation.
Why Join Us?
- Impactful Leadership: Play a central role in shaping the medical operations of a leading early-phase clinical research unit.
- Professional Growth: Lead a dedicated medical team and develop expertise at the forefront of clinical research.
- Collaborative Culture: Work within a highly skilled, cross-functional team dedicated to advancing medical science.
- Patient-Centered Mission: Contribute directly to the development of new treatments in a setting that prioritizes participant safety above all.
If you are a medical leader passionate about clinical research excellence and ready to guide a team in a dynamic early-phase environment, we encourage you to apply.
Apply now for the Medical Operations Manager position.
- We are an equal opportunity employer committed to creating an inclusive and diverse workplace.
