Associate Medical Director (China-Beijing/Shanghai)
QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
If that is your passion, we have a place for you.
Associate Medical Director
- 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.
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
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