Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects. Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
Essential Functions
Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.
Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
May provide therapeutic area/indication training for the project clinical team.
Attends and may present at Investigator Meetings.
Performs review and clarification of trial-related Adverse Events (AEs).
May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
May perform medical review of adverse event coding.
Performs review of the Clinical Study Report (CSR) and patient narratives.
Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
Qualifications
Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
Specialty Board certification in relevant specialty area preferred.
Typically requires 3 – 5 years of prior relevant experience in general clinical medicine including experience in the requested applicable medical specialty area or equivalent combination of education, training, and experience.
Current knowledge of medical, scientific, and clinical landscape in applicable therapeutic area
Good communication, presentation, and interpersonal skills, including good command of English language (both written and spoken)
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Attention to details, flexibility, and ability to provide advice on multiple assignments.
Infectious Diseases specialty area preferred.
Current and valid country/state medical license or equivalent, from the country or region in which he/she resides and works.
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