Senior Medical Monitor

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 Novotech sponsored clinical trials.

• Follow up any medically oriented safety or protocol related questions or queries directly with the Investigator as required.

• Provide ad hoc medically oriented protocol advice to Investigators.

• Lead or participate in Data Safety Monitoring Board (DSMB) activities according to the DSMB charter.

• Review and provide medical input to individual case safety narratives prepared for serious and significant adverse events for CIOMS/MedWatch and clinical study reports.

• Medical review of data listings to highlight and interpret trends.

Experience and Qualifications

• Medical degree from an accredited and internationally recognized Medical School

• Medical Specialist qualification is desirable.

• Knowledge of drug safety reporting requirements and practice

• Experience in clinical practice

• Experience in drug development, pharmacovigilance in the pharmaceutical and/or CRO industry.

• Knowledge of drug safety reporting requirements and practice.Prior mentoring/line management experience will be well regarded

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.