Medical Advisor, Infectious Disease/Vaccine-Eastern Europe
Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.
Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com
To provide medical, clinical, and scientific advisory expertise to all QTRN divisions as requested.
The Medical Advisor participates in all aspects of Medical and Scientific Services’ involvement on assigned trials.
- Primarily acts as back-up Medical Advisor but may serve as a Regional Medical Advisor.
- 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.
EEO Minorities/Females/Protected Veterans/Disabled
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
- No clinical research experience required.
- Ability to establish and meet priorities, deadlines, 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; or equivalent combination of education, training and experience
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Extensive use of keyboard requiring repetitive motion of finger.
- Regular sitting for extended periods of time.
- Frequent travel.
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