Director, Medical Monitoring -Remote Opportunity

Director, Medical Monitoring -Remote Opportunity

Director, Medical Monitoring -Remote Opportunity

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Accentuate Staffing is working with a top International mid-sized CRO to find a Director, Medical Monitoring.  This is a great opportunity to work in a collaborative environment and have input into the company’s clinical strategy.  This position works remotely.

Responsibilities:

  • Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies
  • Extensive interaction with academic thought leaders to optimize clinical trial strategies and clinically manage the conduct of the clinical trials
  • Collaborate with Project Management, Clinical Operations and all departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts and different scientific presentations
  • Identify Program risks, and create and implement mitigation strategies with Clinical Operations
  • Responsible for review and analysis of clinical data including safety monitoring
  • Ability to organize and lead clinical development advisory boards and safety monitoring boards
  • Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
  • Review and sign off clinical documents with respect to medical relevance

Requirements:

  • M.D. degree; oncology or hematologist-oncologist
  • Board certified Oncologist with an active US medical license
  • Minimum 10 years total clinical research experience
  • Knowledge of key opinion leaders in the areas of oncology/hematology highly desirable
  • Familiar and comfortable with clinical concepts, practices and FDA regulations regarding clinical research trials experience with FDA interactions leading to drug approval strongly preferred
  • Familiar with data processing methods plus general knowledge of clinical medicine, oncology and medical terminology
  • Ability to interact with and train clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organization
  • Must possess excellent leadership, communication, and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance