Associate Medical Director/ Medical Monitor (Respiratory) (R1118419) in Buenos Aires, Argentina at IQVIA™

Date Posted: 2/11/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    2/11/2020
  • Job ID:
    R1118419

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

The Medical Monitor (or Associate Medical Director) 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.

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.

REQUIREMENTS:

  • Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education
  • Specialty Board certification in respiratory area (pulmonology)
  • 5 - 7 years of prior relevant experience in general clinical medicine including experience in pulmonology (respiratory diseases)
  • 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.
  • Excellent communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
  • 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.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1118419