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gcp clinical trials ich guidelines patient safety medical monitoring
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πŸ“‹ Description

  • Provide medical monitoring for clinical trials, safeguarding participant well-being and ensuring
  • Review and assess adverse events (AEs), serious adverse events (SAEs), and suspected unexpected
  • Support adherence to Good Clinical Practice (GCP), International Council for Harmonisation (ICH)
  • Contribute to protocol development, investigator meetings, study start-up activities, and
  • Provide medical input into study design, feasibility assessments, risk management, and protocol
  • Contribute to the preparation and review of Clinical Study Reports, investigator brochures

🎯 Requirements

  • Medical degree or equivalent qualification in medicine.
  • Clinical experience in a hospital or comparable healthcare setting.
  • Previous medical research experience in a clinical research organization (CRO), pharmaceutical
  • Strong knowledge of GCP, ICH guidelines, and regulatory requirements governing clinical trials.
  • Demonstrated ability to evaluate clinical trial data, assess safety trends, and make sound medical
  • Understanding of clinical research methodologies, clinical study design, and relevant statistical

🎁 Benefits

  • Competitive salary range: The advertised annual salary range is USD 120,000–250,000, with the final
  • Remote work: Remote working arrangement, subject to the applicable location and employment terms.
  • Professional development: Opportunities to develop expertise and advance professionally in clinical
  • Flexible work programs: Access to flexible working arrangements, subject to role and location.
  • Global collaboration: Opportunities to work with international colleagues across clinical
  • International exposure: Potential opportunities for global collaboration and travel, depending on
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