Regional Clinical Operations Specialist

hace 2 semanas

Madrid, Madrid, España Icon A tiempo completo
Job Summary

At Icon, we are seeking a highly skilled Regional Clinical Scientist to join our team. As a key member of our Global Clinical Operations department, you will play a critical role in supporting the execution of clinical studies and ensuring the highest level of quality and safety.

Key Responsibilities
  • Provide scientific and clinical support to ongoing early and late-stage clinical trials, with a focus on protocol-specific, in-life clinical data monitoring activities.
  • Serve as a point of contact for Contract Research Organizations (CROs), Investigators, and study staff in day-to-day safety monitoring, under the guidance of the Study Medical Monitor.
  • Support the Study Clinical Scientist in medical surveillance and medical monitoring activities, including daily medical surveillance of laboratory and ECG alerts, review of eligibility criteria, and assessment of clinical trial data.
  • Generate study safety events trackers, periodic medical monitoring reports, and safety reviews, as needed.
  • Participate in cross-functional study execution team activities, including clinical data review, and contribute to the development of clinical and regulatory documents.
  • Interact with internal and external stakeholders, including study sites and vendors, to support clinical trial objectives related to subject safety and clinical data monitoring.
Requirements
  • Life sciences degree (BS, MS, or Ph.D.) with clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting.
  • Experience in analysis and interpretation of clinical data, including safety and efficacy, and working knowledge of Good Clinical Practice (GCP) and clinical trial execution.
  • Experience working with clinical trial sites and all stages of drug development.
  • Ability to make independent, timely, and appropriate decisions, and handle multiple projects simultaneously.
  • Excellent oral and written communication skills, and solid computer and analytical skills.
  • Ability to work collaboratively in a fast-paced, team-based matrix environment, and function independently as needed.

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