justin scarfeo

Responsible for the Device and Diagnostic Clinical Trials division by managing the Device and Diagnostic project managers and associate project managers, including employees located in global offices worldwide. Interface with Client representatives, as well as Agility personnel in applicable functional departments, to ensure the timely initiation and completion of clinical trials. Interact with applicable pharmaceutical, biotechnology clients, vendors, and Agility personnel to ensure that all contractual obligations are met. Manage full range of projects; from small limited-scope projects to full-service, large-scale, complex programs. Participate in business development activities, including leading capabilities and bid defense presentations.

* Managed all aspects of assigned PurTox™ Phase I, II, and III Clinical Studies to ensure timely completion within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. * Contributed to the attainment of an FDA Panel recommendation, by a vote of 7-2, favoring the approval of the Mentor Core Gel Silicone Breast Implant IDE Study, after a 12-year ban of the product. * Conducted Mentor Core Gel IDE, Soft Solid IDE, Alpha 1 IDE, and Becker IDE studies simultaneously with the utmost reliability and efficiency. * Successfully managed over 500 study investigators and sites in Mentor Adjunct Study.

* Manages all assigned project activities and project team members. * Responsible for managing timelines, quality and costs of project deliverables. * Develops project plans, quality and risk management plans as well as continuously improve interdepartmental processes. * Represents Project Management on company-wide project teams. * Contributes to the revision of departmental and interdepartmental Standard Operating Procedures, guidelines, and policies.

Work with customers, SynteractHCR functional areas, and executive management teams to identify opportunities for business process optimization and cost-effective approaches to improving operational processes. Manage a portfolio of projects; focusing on multi-department and large-scale programs across all functional areas.

Responsible for the Device and Diagnostic Clinical Trials division by managing the Device and Diagnostic project managers and associate project managers, including employees located in global offices worldwide. Interface with Client representatives, as well as Agility personnel in applicable functional departments, to ensure the timely initiation and completion of clinical trials. Interact with applicable pharmaceutical, biotechnology clients, vendors, and Agility personnel to ensure that all contractual obligations are met. Manage full range of projects; from small limited-scope projects to full-service, large-scale, complex programs. Participate in business development activities, including leading capabilities and bid defense presentations.

Responsible for leading activities in the Business Excellence functional group to ensure corporate business optimization initiatives are designed, initiated, and managed according to contractual time, quality, and cost parameters. Implements and provides guidance related to Business Excellence processes, oversees the work of Business Excellence staff, and works with other department leaders to define, prioritize, and develop projects and programs. Liaises with customers, SynteractHCR functional areas, and management teams to identify opportunities for business process optimization and cost-effective approaches to improving operational processes. Manages a full range of projects; with preference given to complex, multi-department, large scale programs.