Job Description

TheClinical Development Medical Director(Director)is responsible formedical andscientific oversight, data integrity,and quality of clinicaltrials inInternal Medicine, with direct responsibility forclinicaldeliverables for one or more studies. They may also manage,supervise, and mentorothers.

JOB RESPONSIBILITIES

  • Providesmedical monitoring on one or more clinical trials:

  • Providestimely,study-related medical information andguidance, e.g., on:

  • Medical questionsfrom investigatorsites

  • Medical issues inclinical trial data

  • Medical findings in audits or inspections

  • Contributesto medical assessmentsof Quality Events

  • Conducts and documents periodic safety data review and ongoing clinical/medical data review

  • ReviewsRequiredSafetyTextfor the Informed Consent Documentand significantmedical changesin the Informed Consent Document

  • May independently l...

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