Scott Benner

Background

About Scott Benner

Seasoned by the Pharmaceutical Clinical Trials industry, my experiences include- Clinical and Pharmaceutical lab generalist as well as a specialist in Special Chemistry and RadioImmunoassay- Performed maintenance, QC, calibrations, routine and batch testing, and error troubleshooting on most laboratory instrumentation- Reviewed, resulted and reported patient laboratory test values in both clinical and referral lab type settings- Custom-Configured proprietary LIMS systems for the receipt, storage of clinical trial patient samples- Custom-Configured proprietary LIMS systems for the reporting of clinical trial patient results- Custom-Configured proprietary LIMS file formats for transfer of patient laboratory data to clinical trial customers- Worked in collaboration with like-minded highly-motivated entrepreneurial types to drive and support the creation of a new department designed to satisfy compliance monitoring and reporting needs of clinical trial sponsors- By my own accord, worked in close quarters with user groups in order to receive immediate development feedback and promote genuine camaraderie between development and production areas- Built, validated, and provided technical support for compliance monitoring and reporting software tools- Adhered to the FDA Title 21 CFR Part 11 regulations with regards to all development for pharmaceutical protocol clinical trials- On multiple occasions, volunteered to travel alone to monitoring/reporting the satellite location in Europe to provide training, and to promote global collaboration and goodwill- Supervised a clinical monitoring team of eight employees. Managed work assignment schedules, created department commercial policies, common policies, and department standard operating procedures. Responsible for mid-year and year-end performance reviews. Ensured global business continuity during period of new global manager search (period of approx 6 months).