Medical Advisor/Associate Medical Director

Santé et Soins à domicile

24/06/2020

Medical Advisor/Associate Medical Director

Medical Advisor/Associate Medical Director.

We're looking for a candidate to fill this position in an exciting company.

• Medical Monitoring:

• Primarily serves as regional and/or global 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.

• Medical Strategy:

• Provides expert advises to the development of medically sounded delivery strategies for small to large and/or complex multi-region studies in partnership with sales and other functions responsible for business development activities.

• Responsible for the development of the medically related aspects of client proposals including the budget related to medical monitoring.

• Provides medical and scientific ...

  • Type d'emploi
    Temps plein

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Recruteur

IQVIA

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