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gcp clinical trials ophthalmology rave gene therapy

๐Ÿ“‹ Description

  • Design and write clinical protocols and documents (ICFs, charters, manuals)
  • Expert on clinical study design; develop training for sites
  • Support cross-functional teams; point of contact for trial procedures
  • Engage trial vendors for study start-up per design
  • Medical monitoring oversight of CRO activities; review efficacy data
  • Lead or collaborate on clinical sections of regulatory submissions

๐ŸŽฏ Requirements

  • MD/PhD/OD/PharmD with ophthalmology & retina; Gene Therapy preferred
  • 5-7 years clinical research; 3-5 years in clinical science/development
  • GCP/ICH, drug development, study design, statistics; cross-functional
  • Data review, trend ID, interpretation; data monitoring committee knowledge
  • CRO/vendor experience; Phase I-III US & Global/Ex-US trials
  • Strong communication and medical writing; MS Office; RAVE/J-Review
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