Oversees clinical operations developing the infrastructure to support advanced clinical trials.

Responsibilities:       

·        Assess resource requirements for clinical projects.

·        Manages clinical trials from an administrative and field operations perspective.

·        Oversight of investigational sites, contract CRO’s and contract field monitors to ensure all clinical research projects are adequately resourced and proceeding as scheduled, as per budget and as per current Good Clinical Practices.

·        Report on the status of the clinical studies to Company.

·        Assists Clinical Research in preparation of Clinical Development Plans and Clinical Research Protocols.

Qualifications:           

·        Bachelor’s Degree

·        Five or more years of clinical research experience.  

·        Strong familiarity with cGCPs and understanding of Part 11 Compliance (electronic data system compliance).