Medical Director, Medical and Scientific Services - Oncology & Hematology
QuintilesIMS
Buenos Aires, Argentina
hace 5 días

RESPONSIBILITIES

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
  • sites.

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