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Medical Director
hace 2 meses
The medical department at Iqvia is a dynamic team of professionals who provide medical and scientific support to clinical research programs, study teams, and investigators. As a Medical Director, you will play a crucial role in providing 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.
Key Responsibilities- Function as a project team member and provide medical and scientific input to clinical research programs.
- Review and provide input for protocol development, including interactions with clients regarding drug development programs, study design, and protocol.
- Establish and maintain a network of medical/scientific consultants and supervise and manage Medical Director activities.
- Interact with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints.
- Participate in subject recruitment and retention activities, including individual calls to key opinion leaders, investigators, and site staff and/or participation in teleconference and WebEx presentations.
- Present protocol and/or safety reporting information at investigator meetings and develop project medical monitoring plans as requested.
- Provide on-call coverage for protocol queries and site support and provide first-line contact for investigators and monitors regarding study-related medical/safety issues and resolution of study protocol and patient eligibility issues.
- Verify the medical accuracy of patient safety data and maintain an ongoing assessment of the safety profile of the study.
- Review and provide input on IND/SUSAR Safety Reports, updates to Investigator Brochures, and annual IND reports with sponsor data.
- Interact with appropriate FDA officials concerning safety and other study-related issues, as requested.
- Provide medical review of eCRFs for clinical accuracy, medical review of data analysis plan, and review of safety fields at case freeze for reconciliation (if needed).
- Review medical coding of adverse events, laboratory data, and concomitant medications for accuracy, coherence, consistency, and trends.
- Review data tables, listings, and figures and review and/or write portions of final clinical study report.
- May assist sponsor in choosing committee members, serve as a non-voting member to convene and organize proceedings, and develop operating guidelines in conjunction with committee members and submits these to sponsor for review.
- Ensure DSMB feedback is given to sites for IRBs and determine data flow with sponsor to ensure reporting accuracy.
- 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.
- Current or prior license to practice medicine; board certification/eligibility ideal (Preference).
- Board Certified/Board Eligible: Oncology/Hematology (Required).