Medical Advisor/Associate Director (Rheumatology)

Essential Functions:

• Medical Monitoring:

• Primarily serves as 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 sites.

• May require regular travel.

• Extensive use of keyboard requiring repetitive motion of fingers.

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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