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
Must be qualified as a Medical Doctor with experience in clinical practice
Responsibilities
- Perform Medical Monitoring work with a larger portion as a global/program level Medical Monitor.
- 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 drug safety monitoring boards (DSMB), 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 own medical knowledge.
- Coordinate, supervise, coach and support assigned Medical Monitors in order to improve their service delivery.
- Mentor/line manage assigned Medical Monitors.
Experience and Qualifications
- Medically qualified with 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"
- Expertise in complex study designs, wide range of therapeutic indications and ability to assess scientific data.
- Computer literate with good experience in using Microsoft Office (Word, Excel, Power Point)
- Demonstrated ability to deliver work in a fast-paced environment and to independently set priorities and solve problems under tight timelines.
- Attention to detail, strong initiative, critical thinking skills and follow hrough are essential for this job
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 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 contacting you regarding your application