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.

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