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Responsibilities include but are not limited to: protocol approval, conduct of the study experiment according to protocol, documentation of protocol deviations and amendments, reviewing data, approving data analysis, ensuring accurate incorporation of results and conclusions into the study report prior to submission to the Sponsor, working closely with the Sponsor to complete the study, and archiving of study records. The Study Director is responsible for meeting study timelines and quality standards, and eventually for training staff scientists in study-related standard operating procedures.
The desired candidate should possess analytical and interpretive skills in preclinical diagnostic laboratory data (hematology, clinical chemistry, cytology, surgical pathology); as it relates to preclinical studies for product drug product registration. Should possess basic principles of pathophysiology and disease; data quality control, instrumentation and laboratory data management. Good organization skills in managing clinical laboratory operations. Provide guidance to technicians and other study directors wherever appropriate.
The successful candidate will have 2 -5 years of experience; possess excellent written and oral communication skills, with the ability to be a team player. A MS or Doctorate in a Life Science discipline is required.
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