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Job Details


PRA Health Sciences

Sleep Laboratory Manager

Pharmaceuticals

All

Full Time

On Site

No

Silver Spring, Maryland, United States

Duties/Responsibilities:

  • Teach practices (FDA regulations, rules, and policies affecting conduct, record-keeping, and monitoring of human protocols involving investigational new drugs.) to others (students, enlisted soldiers, etc.) as appropriate, and to monitor study data collection procedures to ensure uniformly high levels of compliance with FDA-required practices throughout all phases of the study: preparation, conduct, analysis, and archiving of clinical data.
  • Oversee technical and logistical aspects of the conduct of human research in the fields of: sleep, sleep deprivation, electroencephalography, psychophysiology, and others—and aids in the statistical analyses, presentation, and publication of resulting data sets – to include assisting in the preparation of any progress and/or final reports to the FDA and/or commercial (e.g., pharmaceutical industry) sponsors of IND research.

Qualifications:

  • Knowledge of/experience with FDA regulations, rules, and policies affecting conduct, record-keeping, and monitoring of human protocols involving investigational new drugs.
  • Ability to teach these practices to others (students, enlisted soldiers, etc.) as appropriate, and to monitor study data collection procedures to ensure uniformly high levels of compliance with FDA-required practices throughout all phases of the study: preparation, conduct, analysis, and archiving of clinical data.
  • Knowledge of ICH/GCP and FDA/CFR guidelines for pharmacological agents used in human use research or past related experience showing the ability to master similar skills is a critical requirement.

ICON Government and Public Health Solutions specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.