The Clinical Scientist serves a medical research function and applies a broad knowledge of clinical research activity, therapeutic area knowledge and regulatory requirements to facilitate the development and implementation of clinical studies. The primary objective and purpose of this position is ensuring that clinical trial protocols and study reports are developed and written with scientific rigor. He / she is responsible for all aspects of clinical science including research, developing and writing study protocols, investigator brochures, study summaries, clinical study reports, or other clinical documents. The Clinical Scientist will oversee the scientific aspects of clinical studies throughout the duration of the study and may be asked to respond or provide guidance to address questions regarding scientific and related procedural issues from investigators. He / she will support clinical teams as the medical writing representative, bearing the responsibility for timely and accurate completion of medical writing deliverables.
The Clinical Scientist works closely with Medical affairs at Corporate and Business Units, Principal Investigators and statisticians to develop clinical documents. He / she may present or assist with preparing responses to regulators or present data to data monitoring committees, investigators, etc.
* Additional areas of responsibility as assigned.