Assoc. Medical Director

hace 2 semanas

Buenos Aires, Argentina IQVIA A tiempo completo
This Medical Advisor role will provide medical, clinical and scientific advisory expertise to all IQVIA divisions as requested. Participate in all aspects of Medical Science involvement on assigned trials.

Serve as a medical expert during project delivery life-cycle. Provide therapeutic medical and strategic expertise to business development activities.

RESPONSIBILITIES:
The role includes predominantly Medical Monitoring responsibilities and Medical Strategic inputs as requested. This is a global role.

  • 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 protocolrelated 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 trialrelated 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 protocolrelated issues at the investigative sites.

REQUIREMENTS:

  • Excellent communication, presentation and interpersonal skills, including the command of
    English language (both written and spoken).
  • Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education
-
Certification as a Psychiatrist (mandatory):

years of prior relevant experience in general clinical medicine.

  • Previous clinical research experience as an investigator or in the Pharma, CRO, or Biotech industry is required; or equivalent combination of education, training and experience
  • Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
  • Strong Business Acumen.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Excellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.

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