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Associate medical director, cardiology-metabolic diseases and nephrology experience (m/w/d)

Milano
IQVIA
Pubblicato il 8 gennaio
Descrizione

Ph3Overview /h3pThe Associate 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 the project delivery lifecycle. Provide therapeutic and medical expertise to business development activities. /ph3Responsibilities /h3ulliPrimarily serves as Global Medical Advisor on assigned projects. /liliServes as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects. /liliProvides 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. /liliPerforms medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). /liliProvides therapeutic area/indication training for the project clinical team. /liliAttends and presents at Investigator Meetings. /liliPerforms review and clarification of trial-related Adverse Events (AEs). /liliMay perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives, in collaboration with the Pharmacovigilance department. /liliMay provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of the Pharmacovigilance department. /liliMay perform medical review of adverse event coding. /liliPerforms review of the Clinical Study Report (CSR) and patient narratives. /liliAttends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. /liliAvailable 24/7 to respond to urgent protocol-related questions from investigative sites, in accordance with local labor laws. /liliMay require regular travel to the US (15%-20%). /li /ulh3Qualifications Requirements /h3ulliMedical Degree from an accredited and internationally recognized medical school 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 4 years' clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry. /liliRobust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area. /liliKnowledge of applicable federal and local regulations and guidelines pertaining to clinical research. /liliBusiness Acumen. /liliA board-certification for the required therapeutic area. /liliKnowledge of cardiology, metabolic diseases and nephrology. /liliExperience or knowledge in Phase I studies or early clinical development. /liliFluent English. /liliExtensive communication skills. /li /ulpIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at /p /p #J-18808-Ljbffr

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