Associate Medical Director (China-Beijing/Shanghai) - (1609417) in Shanghai, CN at IQVIA™

Date Posted: 10/11/2018

Job Snapshot

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Join us on our exciting journey!
IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
 PURPOSE
Manage facilities within a specific site, coordinating efforts of internal groups, building management and vendors to ensure efficient facilities operations whilst adhering to the Company’s Policies and Procedures and providing an outstanding level of service.
 Associate Medical Director
 
RESPONSIBILITIES
  • Serves as Regional Medical Advisor on 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 review and clarification of trial-related Adverse Events (AEs).
  • Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative.
  • Provides medical support for the Analysis Of Similar Events (AOSE).
  • Performs medical review of Adverse Event coding.
  • Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
  • Performs review of the Clinical Study Report (CSR) and patient narratives.
  • Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
  • Attends and presents at Investigator Meetings.
  • Provides therapeutic area/indication training for the project clinical team.
  • Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
  • Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects.
  • Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study.
  • Participates in development of Medical and Scientific Services portion of client proposals including the budgeting process.
  • Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services.
 
 

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to regulatory affairs
  • Ability to establish and meet priorities, deadlines, strategic department goals and objectives
  • Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and works is required, plus a minimum of 5 years' experience in clinical medicine, in addition to 2 years' clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or equivalent combination of education, training and experience
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: 1609417