Associate Medical Director- Psychiatry

IQVIA

On-site

Regular employment

9 - 15 years of experience

Full Time

Sofia, Bulgaria

Responsibilities

Job Overview

The Associate Medical Director / 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

Medical Monitoring:

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

Medical degree from an accredited and internationally recognized medical school , 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 4 years' clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry.
Specialty Board certification required.
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

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

Required skills

Business Development

English

Job posted 5 days ago

Responsibilities

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.

Specialty Board certification required.

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

Required skills