Associate Medical Director, Psychiatrist

Job Level: Associate Medical Director, Psychiatry

Location: Home-based in the U.S

Job Overview

Primarily acts as global and regional Medical Advisor but may serve as back-up 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.

Essential Functions

• Primarily acts as back-up Medical Advisor but may serve 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.
• May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
• May provide therapeutic area/indication training for the project clinical team.
• Attends and may present 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 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.

Qualifications

• Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education (mandatory).
• Specialty Board certification in relevant specialty area preferred: Psychiatry (mandatory).

• Advanced English level - both written and spoken (mandatory).
• 3 - 5 years of prior relevant experience supporting clinical trials, as Investigator, Sub-Investigator, or other related role in Pharma or CRO.
• Current knowledge of medical, scientific and clinical landscape in applicable therapeutic area.
• Good communication, presentation and interpersonal skills in Spanish and English.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Attention to details, flexibility and ability to provide advice on multiple assignments.
• Current and valid country/state medical license or equivalent, from the country or region in which he/she resides and works.

#LI-Remote

#LI-NITINMAHAJAN

IQVIA 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 https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.