JobMesh

Senior Medical Monitor

Novotech · AU

The Senior Medical Monitor will be responsible for performing higher complexity medical monitoring tasks, including those as a global/program medical monitor...

Job description

About the Role The Senior Medical Monitor will be responsible for performing higher complexity medical monitoring tasks, including those as a global/program medical monitor. The SMM may also mentor/line manage a small number of assigned medical monitors. The SMM activities will include coordination and delivery of training, participation in the development and revision of medical monitoring SOPs, contribution to improving the performance of the medical monitoring team and close liaison with Business Development in medical guidance on protocol and project requirements. Responsibilities: - Provide medical oversight for Novotech sponsored clinical trials, acting as medical representative to the Novotech project team. - Prepare a Medical Monitoring Plan for each study according to project scope. - Provide medical review and commentary on client protocol and/or Investigator Brochure. - Attend Investigator Meeting; prepare and present safety or medical aspects if required. - Provide medical review and input to Clinical Monitoring Plan and Safety Management Plan as required. - Provide medical review, comment and assessment of causality for Serious Adverse Events (SAEs) occurring in Novote...