ProPharma
ProPharma está com vaga(s) de emprego para Medical Director/monitor – Rio De Janeiro em Rio de Janeiro
Cargo:
Medical Director/Monitor – Rio de Janeiro
Requisitos:
Please submit resume in English language. Job Summary: The Medical Monitor position is responsible for serving as the primary medical point of contact for a project or study. The Medical Monitor effectively performs and manages medical and safety review, processes, and projects for assigned clinical and post marketing products. Essential Functions Directs the management of medical monitoring during clinical trials and projects and performs all aspects of clinical trial medical monitoring. Completes the medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents. Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice. Manages the evaluation and selection of investigators and study sites as well as analysis of medical activities. Reviews, edits, and oversees medical and safety sections of regulatory document submissions. Participates in Investigator's meetings as needed. Other duties as assigned. Necessary Skills and Abilities: Excellent understanding of the clinical / pharmaceutical process to effectively communicate and create required deliverables. Advanced knowledge of, and ability to, apply GCP and all applicable regulations and guidelines. Exceptional leadership skills and proven industry vision. Ability to understand complex clinical and statistical data and issues from an analytical standpoint. Effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents. Track record of execution on large scale programs that meet quality, time and budget requirements. Educational Requirements: A Doctor of Medicine (MD) and preferably board certification. Experience Requirements: 5+ years post residency, clinical experience Oncology trained (fellowship, additional board certification etc.) Clinical research experience OR CRO experience Oncology clinical trial experience required Fluency in English, Spanish & Portuguese preferred
Salário:
A combinar
Benefícios:
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