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Medical Director Oncology Hematology Specialist
1 semana atrás
The Medical Director plays a crucial role in providing medical and scientific support to clinical research programs, study teams, and investigators. This individual serves as the primary contact for the sponsor medical team and provides front-line medical resource to support the project team.
- Functions as project team member collaborating with multidisciplinary groups of colleagues.
- 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 Good Clinical Practice (GCP) standards and operate with highest efficiency.
Essential Functions:
- Supervises and manages Medical Director activities to ensure effective project delivery.
- Interacts with clients regarding drug development programs, study design, and protocol.
- Reviews and provides input for protocol development, interacting with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints.
- Develops project medical monitoring plans as requested.
Safety Monitoring and SAE Reporting Activities:
- Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study.
- Provides medical review of Serious Adverse Event (SAE) reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries.
Business Development Activities:
- Assists Business Development in actively soliciting new business opportunities for IQVIA Biotech Clinical, including assistance with marketing presentations and proposal development.
- Supports business development activities with proposal development and sales presentations.
