Job Overview
The medical department consists of a Chief Medical Officer, Medical Directors, Sr Medical Directors, Medical Writers, and Safety Associates. The Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Medical Director also provides review, advice, and leadership for potentially or awarded clinical research programs.
Essential Functions
The Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team.
The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below:
Functions As Project Team Member
- Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation, and reporting.
- Ensures medical activities run according to GCP and operate with highest efficiency.
- Establishes and maintains a network of medical/scientific consultants, etc.
- Supervises and manages Medical Director activities.
Clinical Activities
- Interacts with clients regarding drug development programs, study des
📌 Medical Director (Roma)
🏢 Iqvia
📍 Roma