Description:
About the Role
The Senior Medical Monitor 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
- Perform medical monitoring work with a larger portion as a global/program level medical monitor.
- Keep up to date with current and scientific knowledge in the medical field.
- Work closely with business development and other internal stakeholders in critical appraisal of protocols, proposing study designs and endpoint development.
- Regular participation in project proposals/bid defence meetings and client liaison.
- Set up/support adjudication committees.
- Participate in global/program level governance committee reviews.
- Lead with a data-driven and compliance mindset including detection of trends and outliers, signal detection.
- Provide technical medical support to the team through their own medical knowledge.
- Coordinate, supervise, coach and support assigned medical monitors to improve their service delivery
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 global medical monitoring and program level medical oversight including review of all or critically relevant data for consistency, coherency, reliability and medical "logic"
- Experience in complex study designs, wide range of therapeutic indications and ability to assess scientific data
- 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.