Associate Medical Director

5 days ago

Singapore IQVIA Full time

**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.

**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.

**Qualifications**:

- 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
- 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.
- 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.

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