• Perform and coordinate all aspects of clinical monitoring and site management process in accordance with ICH, GCP, FDA Guidelines, local regulations and client SOPs • Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites • Conduct site visits to assess protocol and regulatory compliance and manage required documentation • Conduct training, authorization and performance assessment visits with CRAs • Develop and maintain collaborative relationships with investigational sites • Feasibility process; recruit investigators for participation in clinical trials • Negotiate study budgets with investigators • Review Tables and Listings generated from study data with the use of data analysis tools for completeness, consistency, accuracy and trending analysis; • Monitoring visit report reviewing • Preparation of clinical trial sites to regulatory inspections