The role includes predominantly Medical Monitoring responsibilities and Medical Strategic inputs as rrequested.
Medical Monitoring :
Serves as Global and / Regional Medical Advisor on assigned projects.
Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects
of 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.
Performs medical review of the protocol, Investigative Drug Brochure (IDB), and / or Case Report Forms (CRFs).
Provides therapeutic area / indication training for the project clinical team.
Attends and presents 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
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