Medical Director- Oncology / Hematology (Home-Based)

The medical department consists of a Chief Medical Officer, 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.

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 the primary contact for the sponsor medical team and to serve as a frontline 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, compliance issues, and to review alert labs per sponsor preference. Major duties of the Medical Director are outlined below :

Essential Functions

• Functions as a 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, adverse event evaluation and reporting
• Ensures medical activities run according to GCP and operate efficiently
• Establishes and maintains a network of medical / scientific consultants
• Supervises and manages Medical Director activities
• Clinical Activities : Interacts with clients regarding drug development programs, study design, and protocol development. Reviews and provides input for protocol development, including collaboration with key thought leaders and sponsor representatives to develop inclusion / exclusion criteria and study endpoints. Provides project team training on protocol and therapeutic areas. Assists in developing criteria for investigator site selection and networking for potential investigators. Participates in subject recruitment and retention activities, including calls to key opinion leaders and investigators, and presentations at meetings.
• Develops project medical monitoring plans as requested
• Provides on-call coverage for protocol queries and site support. Acts as the first-line contact for investigators and monitors regarding study-related medical / safety issues and resolution of protocol and patient eligibility issues.
• 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 SAE reporting, writes / reviews SAE narratives, and collaborates with the Safety Management Department to track and follow up on safety queries
• Reviews IND / SUSAR Safety Reports, updates to Investigator Brochures, and annual IND reports with sponsor data
• In consultation with the sponsor, follows procedures for knowledge of subject treatment assignments (breaking the blind)
• Interacts with FDA officials concerning safety and study-related issues as requested
• Data Activities
• Provides medical review of eCRFs, data analysis plans, and safety data reconciliation
• Reviews medical coding of adverse events, laboratory data, and medications for accuracy and trends
• Reviews data tables, listings, and figures; contributes to final clinical study reports
• DSMB / Adjudication Committee Activities
• May assist in selecting committee members and organizing proceedings
• Develops operating guidelines and ensures accurate data flow reporting
• Ensures DSMB feedback is communicated to sites for IRBs
• Note : DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group
• Business Development Activities
• Supports business development through proposal development, marketing presentations, and feasibility discussions
• Special Projects
• Conducts literature searches, assists with SOP drafting, participates in quality improvement efforts, and performs other duties as assigned by the Chief Medical Officer

Qualifications

IQVIA is a leading global provider of analytics, technology solutions, and clinical research services. We aim to push the boundaries of human and data science to impact health worldwide. Learn more at

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