Medical Director
4 semanas atrás
Job Overview
The Medical Director role at IQVIA is a key position that requires a medical professional with expertise in oncology and hematology. The successful candidate will provide medical and scientific support to clinical research programs, study teams, and investigators.
Key Responsibilities
• Provide 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
• Ensure medical activities run according to GCP and operate with the highest efficiency
• Establish and maintain a network of medical/scientific consultants
• Supervise and manage Medical Director activities
Clinical Activities
• Interact with clients regarding drug development programs, study design, and protocol
• Review and provide input for protocol development. Interact with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints
• Provide project team training on protocol and/or therapeutic areas
• Assist team with developing criteria for investigator site selection and networking for potential investigators for study participation
Safety Monitoring and SAE Reporting Activities
• Verify the medical accuracy of patient safety data and maintain an ongoing assessment of the safety profile of the study
• Provide medical review of SAE reporting, write and/or review SAE narratives, and work with the Safety Management Department to track SAEs and follow-up on outstanding safety queries
Data Activities
• Provide medical review of eCRFs for clinical accuracy
• Provide medical review of data analysis plan
Qualifications
• Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education
• 10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development
• 3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year experience
• Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus
• Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment
• Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
• Excellent oral and written communications skills as well as interpersonal skills are essential
About IQVIA
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
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