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Medical Project Coordinator

Thermo Fisher Scientific · Santiago et périphérie

🇬🇧 English
SAE processing safety data trending coding biostatistics data management clinical procedures

Descripcion del puesto

About the role

The Medical Project Coordinator will support drug safety operations within clinical trials, ensuring regulatory compliance and patient safety. This role involves coordinating safety data review, trend analysis, and communication with investigators and project teams.

Key responsibilities

  • Coordinate and review safety data using line listings, dashboards, and visualization tools.
  • Identify safety trends, coding inconsistencies, and potential follow‑up actions with investigator sites.
  • Prepare safety summaries for review meetings and contribute to aggregate report sections.
  • Assist in creating and reviewing safety and medical management plans to align with contracts.
  • Monitor project implementation, forecasting, metrics, and budget considerations.
  • Escalate data review delays or risks to stakeholders and study leads.
  • Present findings at business development, client, and investigator meetings.
  • Serve as primary contact for clinical and data‑management project teams and support training and mentoring activities.

Required profile

  • Bachelor’s degree in nursing, health sciences, Physician Assistant, or licensed RN.
  • At least 2 years of clinical safety experience (clinical research monitoring, pharmacovigilance, or a combination).
  • Strong problem‑solving, critical‑thinking, and communication skills.
  • Ability to work collaboratively and maintain professionalism in challenging situations.

Required skills

  • Good Clinical Practice (GCP) knowledge for medical oversight of clinical trials.
  • SAE processing and drug‑development safety reporting.
  • Safety data trending and coding expertise.
  • Working knowledge of biostatistics, data management, and clinical procedures.

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Publicado hace 2 semanas

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Thermo Fisher Scientific

Santiago et périphérie