Medical Monitor - Australia
About the Role
The Medical Monitor will be responsible for performing higher complexity medical monitoring tasks, including those as a global/program medical monitor. The MM may also mentor/line manage a small number of assigned medical monitors. The MM 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.
Novotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.
