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The Clinical Development Medical Director (Associate Director) is responsible for medical and scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies. They may also supervise and mentor others.
JOB RESPONSIBILITIES
Provides medical monitoring on one or more clinical trials:
Provides timely, study-related medical information and guidance, e.g., on:
Medical questions from investigator sites
Medical issues in clinical trial data
Medical findings in audits or inspections
Contributes to medical assessments of Quality Events
Conducts and documents periodic safety data review and ongoing clinical/medical data review
Reviews Required Safety Text for the Informed Consent Document and significant medical changes in the Informed Consent Document
Provides clinical support for one or more studies; ma...