Senior Method Development Scientist (Future Opportunities in Ithaca, NY) (R1115177) en Ithaca, NY de IQVIA™

Fecha de publicación 3/28/2020

Resumen de la oferta

  • Tipo de empleado:
    Tiempo completo
  • Ubicación:
    Ithaca, NY
  • Experiencia:
    Not Specified
  • Fecha de publicación
    3/28/2020
  • ID del Empleo:
    R1115177

Descripción del trabajo

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Summary

The 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 lifecycle. 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.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1115177