Medical Director - EU

Sitero

Warsaw, Poland

DESCRIPTION:

The Medical Director will assist the medical monitoring in managing all medical aspects of clinical trials. The Medical Director administers the Sitero Mentor Event Reporting system to facilitate the evaluation and reporting of adverse events, serious adverse events and adverse event of special interest. The Medical Director will be responsible for preparing listings of protocol deviations and adverse events for regular meetings, performing initial review for coding and reconciling coding based on the inputs of the clinical and medical teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Prepare and review protocol deviation listing;
  • Code protocol deviations per protocol deviation guidance;
  • Prepare draft of medical monitoring plan for the medical monitoring;
  • Query CRAs for clarification on protocol deviations;
  • Prepare adverse event listings;
  • Code adverse events and serious adverse events;
  • Assist the medical monitoring in management of clinical trials;
  • Administer Sitero Mentor Event Reporting system.

EDUCATION AND EXPERIENCE REQUIRED:

  • 5 years of experienced working in clinical trials as a medical monitoring associate or equivalent relevant experience;
  • A Medical professional with MD and/or PhD degrees;
  • Conducting and development of gastroenterology and immunology clinical trials;
  • Experience in working in interdisciplinary research team for 3-5 years;
  • Ability to effectively communicate with physicians in English;
  • GI residency with endoscopy experience is a plus.

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