Head of Technology Compliance
Premier Research is a CRO built for biotech, partnering to alleviate uncertainty and speed success in critical clinical trials.
Record of leveraging cutting-edge technology strategies into increased revenue and reduced costs for international and domestic pharmaceutical/CRO companies. Strong history of collaborating with executive team on setting strategic direction and ensuring business continuity while balancing risk management principles and techniques as well as ensuring compliance in system selection, implementation and maintenance in highly regulated environments (FDA, ICH, SOX, HIPAA, 21CFR Part 11, etc.). Exemplary knowledge of domestic and global regulations. Select Accomplishments•Turned around technology implementation processes and enhanced departmental structure. •Reduced reported IT related issues by 50%, while decreasing inter- and intra-departmental tensions. •Increased uptime at Premier Research for critical systems from 99.0 to 99.999. •Developed Validation Service Offering, generating a new revenue stream ($1.2M annually). •Improved understanding and confidence in technology strategies while ensuring funding. •Completed a seamless integration of all IT functions on time and within budget following acquisition. •Successfully transitioned IT function, improving IT support for the company’s German facility. Core CompetenciesCRO • SaaS, PaaS, IaaS • Business Continuity • Strategic Planning • Budget ManagementManagement Reporting • Global Implementations • System Development • Vendor Selection Vendor Management • Process Improvement • Service Delivery • Project ManagementRisk Analysis & Remediation • Regulatory Compliance • Team Leadership
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