Senior Medical Director, Oncology / Hematology (Durham)

Senior Medical Director

The Senior 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 Senior 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.

Essential Functions

• 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 :

Safety Monitoring and SAE Reporting Activities :

Data Activities :

DSMB / Adjudication Committee Activities :

Business Development Activities

Special Projects

Qualifications

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.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.