Job Description
Job Description The Medical Monitor is responsible for management of medical aspects of assigned clinical trials, in accordance with the project scope and Medical Management Plan. The aim of the role is to ensure patient safety aspects of Novotech sponsored clinical trials are appropriately managed.
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. Provide medical review and input to Clinical Monitoring Plan and Safety Management Plan as required.
- Attend Investigator Meeting; prepare and present safety or medical aspects if required.
Qualifications Qualifications for Internal Candidates M.D. Degree required with experience in clinical practice. 5-10+ years of experience in drug development, pharmacovigilance in the sponsor pharmaceutical and/or CRO industry. Knowledge of drug safety reporting requirements and practice. Therapeutic area expertise in Oncology.
Salary Band - Senior Medical Monitor: $200,000 to $260,000 USD - The salary for this position will be determined based on the candidate's experience and qualifications.
Find out more about working at Novotech at:
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.
About Us Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
About the Team Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.
It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.
As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.
Job Tags
Flexible hours,