Associate Medical Director, Cardiology , with Metabolic Diseases and Nephrology Experience

Associate Medical Director, Cardiology , with Metabolic Diseases and Nephrology Experience

Rome, Italy | Full time | Home-based | R1545592

The 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 project delivery lifecycle. Provide therapeutic and medical expertise to business development activities.

Essential Functions

• Primarily serves as Global Medical Advisor on assigned projects.
• Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of 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 medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
• Provides therapeutic area/indication training for the project clinical team.
• Attends and presents at Investigator Meetings.
• Performs review and clarification of trial-related Adverse Events (AEs).
• May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
• May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
• May perform medical review of adverse event coding.
• Performs review of the Clinical Study Report (CSR) and patient narratives.
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• Available 24/7 to respond urgent protocol-related questions from investigative sites, in accordance with local labor laws.

Qualifications & Requirements

• 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 clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry.
• Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
• Business Acumen.
• Board Certified in Cardiology.
• Knowledge of cardiology, metabolic diseases and nephrology.
• Experience or knowledge in Phase I studies or early clinical development.