Senior Medical Monitor

About the role

Novotech, a global full-service clinical CRO, is hiring a Senior Medical Monitor. The role covers higher-complexity medical monitoring, including acting as a global or program medical monitor, and may involve mentoring or line managing a small number of assigned monitors. Only candidates with unrestricted working rights in Australia are considered.

Key responsibilities

• Provide medical oversight for Novotech-sponsored clinical trials and act as the medical representative to the project team.
• Prepare a Medical Monitoring Plan for each study according to project scope.
• Review and comment on client protocols and Investigator Brochures.
• Attend investigator meetings and present safety or medical aspects when required.
• Contribute to the Clinical Monitoring Plan and Safety Management Plan.
• Assess causality for Serious Adverse Events (SAEs).
• Coordinate and deliver training, help develop and revise medical monitoring SOPs, and liaise with Business Development on protocol and project guidance.

Required profile

• Qualified medical doctor with clinical practice experience.
• Experience in drug development in the pharmaceutical and/or CRO industry.
• Knowledge of drug safety reporting requirements and practice.

What we offer

• Flexible working options and paid parental leave for both parents.
• Flexible leave entitlements, wellness programs and ongoing development programs.
• An inclusive workplace with support for LGBTIQ+ people, people with disabilities and those with caring responsibilities.