Clinical Project Manager II

Job Description

Job Description Summary Novartis has over 300 trials currently running that are helping over 96,000 patients worldwide. As a Clinical Project Manager, you will have a key role in providing medical oversight for clinical trials that ensures the trials we do meet our business and strategic objectives, while making a real impact on patients’ lives. As the Clinical Project Manager your responsibility lies within the development of Global Clinical Trials – this includes medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning. You will drive compliance across all aspects of clinical trials and CRMA related activities. It will be critical to ensure good communication and stakeholder management cross-functionally within the local country organisation as well as between global and regional teams. Job Description Medical oversight of clinical trials across all stages and contribute to operational trial deliverables, according to timelines, quality/compliance, and performance standards. Drive portfolio/trial medical feasibility within the Global Development framework and provide country clinical strategic guidance and proposals in collaboration with Study and Site Operations Team and Medical Affairs Team. Identify and propose new sites for clinical trials, analyse capability, assess patient pool and country treatment landscape, and make recommendations for potential trial inclusion. Provide robust indication and protocol training to CRAs, CSMs, RSMs and other functions in the country as needed. Responsible for medical related education, implementation and compliance to protocol, standards (SOPs) and best practices for clinical development within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned. Provide medical expertise to clinical/operational activities for patient eligibility, medical question-management, safety, amendments, etc. Collaborate cross-functionally for the early product launch planning process to ensure Global Development trials conducted are aligned with the local country strategy. Support medical/clinical team discussions with local regulatory interactions as needed. What you’ll bring to the role: Post-Graduate Science qualification is essential. Medical Degree (MD, MBBS) preferred. Proven experience in medical practice or pharmaceutical industry experience with a background in clinical trials/medical affairs/life sciences/research in all aspects of drug development including clinical research, GCP, and local regulatory requirements. Experience in Haematology and Oncology clinical trials is essential. Demonstrated experience in managing projects, feasibility conduct and the execution of strategic plans from a medical perspective. Outstanding internal and external stakeholder engagement experience. Location is based in Sydney, with flexible working options. Skills Desired Auditing, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Data Auditing, Data Management, Health Sciences, Lifesciences, Project Planning, Vendor Management, Waterfall Model #J-18808-Ljbffr