Medical Director

Profile

Summary: Interacts with senior management, customers, and project teams to ensure the safety of subjects in clinical trials; ensures the scientific integrity of the clinical portions of clinical trials; provides medical input to clinical programs; provides clinical development and regulatory consulting advice as needed. Performs the duties of a Medical Monitor. Essential Functions : n Manages subject safety and the scientific integrity of clinical trials. n Responsible for subject-safety and the scientific integrity of clinical trials. n Performs the duties of a Medical Monitor. n Provides 24-hour coverage for clinical trials. n Participates in bids, bid-defenses & feasibility assessments when requested. n Provides project-specific and therapeutic training to sponsors and Company staff as needed. n Works with the Drug Safety Department by providing medical input and oversight. n Works with Medical Writing/Regulatory in the preparation of a variety of documents as required. n Maintains in-depth knowledge of worldwide drug development regulations and Good Clinical Practice (GCP) guidelines. n Interacts with senior management, project management, and other departments as appropriate. n Provides clinical development and regulatory consulting advice both within Company and to clients as requested. n Locates and interacts with outside experts as necessary. n Provides feedback to management on quality issues within the clinical trial team n Represents Company at scientific meetings as required. n Primary senior-level contact for customers. n Assumes line-management duties as needed. n Other Responsibilities: Performs other work-related duties as assigned. Minimal travel may be required (up to 25%). Qualifications: A doctoral-level degree in medicine and must have practiced medicine and have clinical research experience. In-depth knowledge of FDA and worldwide drug-development regulations. Strong understanding of the use of medical terminology and of drug-names in multiple nations, cultures and environments. In-depth knowledge of national and ICH Good Clinical Practice (GCP) guidelines. Basic computer and word-processing skills, including the use of spreadsheets, e-mails and smart-phones. Experience working in matrix-teams. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Effective organizational and interpersonal skills. Skilled at presenting data to groups, and in the creation of effective documentary communication. Customer-focused with a disciplined approach to work with excellent verbal communication and language skills. Fluency in written and spoken English.n,occupationalCategory:Medical Director}

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