Trained medical affairs professionals are highly sought after in the pharmaceutical industry and have many opportunities to grow further.
A Medical Monitor is a qualified medical practitioner who has immense experience and training in a particular therapeutic area such as oncology, diabetes, neurology, infectious diseases etc and related technologies. The most important function of the Medical Monitor is to make sure that the safety of participants in a clinical trial is not compromised at any time in any way.
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Medical Monitors are extensively involved in the design and conduct of Phase I clinical trials and also monitor the progress of all other clinical trial phases. Medical Monitors are recruited by pharmaceutical companies, medical device manufacturers or even by contract research organizations (CRO).
Not only do Medical Monitors perform clinical study related tasks but they also participate in new business development related activities and participate in discussions related to product dossier compilation and product licensing.
Some common expectations from Medical Monitors are to:
– Ensure supervision and coordination of all medical issues related to ongoing clinical research
– Ensure medical and scientific quality of clinical trial protocols
– Support project management teams
– Address safety issues across the study
– Responsible for the medical revision of Investigational Medicinal Product Dossier
– Provide medical expertise to the study team
– Coordinate, review and approve the key study documents such as the protocol
– Identify key opinion leaders for each therapeutic area
– Address safety issues throughout the study
Skills and Competencies:
– Excellent oral and written communication skills
– Leadership skills
– Intellectual with strategic thinking
– Innovative and willing to learn
– Advanced Medical Degree with Registration Certificate
– Advanced PG Diploma in Pharmaceutical / Translational Medicine or Clinical Research is recommended
– Experience in Medical Affairs
For a career as a Medical Monitor we suggest you consider the following online program(s):
"I can say that the modules that I have completed have been very well presented and informative."
Medical Services Manager
Nycomed Pty Ltd, Australia