Job Description
The Gastroenterologist will provide medical, clinical, and scientific advisory expertise to all Quintiles divisions as requested. Incumbent will participate in all aspects of Medical and Scientific Services' involvement on assigned trials. Assists in the implementation of department mission, goals and objectives, oversight of operations, development of policies and procedures and standards for the department.
Responsibilities
Serves as Regional Medical Advisor and/or Global 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 narratives.
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 medical 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 the Investigator Meeting(s).
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.
May provide 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 the development of Medical & 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.
Budget responsibility for large global multi-million dollar programs; responsible for all safety issues on these programs.
Serves as Regional Medical Director and/or Global Therapeutic Head for larger teams and/or regions.
Participates in management level meetings within Medical & Scientific Services.
Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff.
Maintains awareness of industry developments and participates in professional meetings, and may author related publications.
Performs special projects as requested by management.
Qualifications
A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to internal medicine 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, allergy and respiratory area, in addition to 4 years clinical trials/drug development experience
Friday, October 02, 2015
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