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Senior Validation Engineer

JR067402

About the role

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  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
    As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
    * Travel (approximately 15%) domestic and/or international*.
    * Complete all departmental project activities accurately and in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.
    * Serve as the main point of contact for the customer for the life-cycle of assigned stand alone projects, and the main pharmacovigilance point of contact for assigned full-service projects*
    * Ensure the assigned project contracted tasks are completed according to project specific procedures and meet key metrics
    * Oversee implementation of projects including client communications, project specific plans, system set-up, and establishment of appropriate and agreed-upon metrics*
    * Completion of project status reports/review meetings including burn hours, profit margins, quality review findings and other metrics*
    * Lead identification of out of scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required *
    * Coordinate and present at meetings (project and department) as required
    * Support QPPV as required
    * Develop and maintain excellent client relationships
    * Assisting the Director/Senior Director to develop and grow capabilities, productivity, and quality levels.
    * Actively participate in quality and training initiatives
    * Participate in process improvement by actively identifying process improvements, developing better procedures, and working to additionally implement those change / process improvements
    * Interview, evaluate and recommend new PVSS hires
    * Train/mentor Drug Safety Coordinator and other Drug Safety Manager staff*
    * Develop staff for succession planning, ie, develop next generation of management/leaders
    * Coordination and participation in interdepartmental activities (e.g. quality control processes, quality assurance (audits), miscellaneous project activities)
    * Participate in Business Development activities as requested
    * Perform other activities as identified and requested by management
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