Our client is looking for a 10+ year, Medical Monitoring specialist in Oncology. This expert will need to be someone who is readily available to investigator, site, and study team to advise on medical related questions. This person will work closely with Safety and Pharmacovigilance team to provide medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, and Company Core Safety Information (CCSI), etc. This Monitor will Provide Sites with the knowledge to properly evaluate subjects and adhere to the protocol and lead in medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation. Responsibilities will further include escalating any critical safety concerns to the study team and Sponsor, and coordinating between sites and study team/Sponsor.
10+ years’ experience within clinical drug research within the pharmaceutical/ Biotech or CRO industry
10+ years’ of safety databases (ARISg, Oracle Argus, etc.) and/or EDC system (IBM, Medrio, Medidata)
10+ years’ of mentoring and training a medical/safety group
Medical Degree, MD, DO or its international equivalent
Remote in Europe: Medical Monitor (231951)