Job Description
JOB DESCRIPTION:The purpose of the PM/CI Specialist position is to provide Project Management and Continuous Improvement (CI) expertise (e.g. DFSS, Lean, Six Sigma) and aid in embedding a CI culture within Development Operations. - The PM/CI Specialist leads the global development (and implementation as appropriate) of large-impact continuous improvement business process improvements. - This position provides project management oversight and expertise to partner with business lines to drive the development (and implementation as appropriate) of the business process improvements by employing project management, consultancy, change management, continuous improvement, implementation, influencing, and communication methodologies. - Position will drive implementation of Data Quality Framework activities, specifically Quality Gates ResponsibilitiesThe key responsibilities of the PM/CI Specialist role include: - Team with a group of subject matter experts to enable Dev Ops to create and sustain a culture of continuous improvement and innovation. - Provide the tools to successfully execute PM/CI initiatives as prioritized. - Knowledge share/Coach Dev Ops colleagues in application of methodologies on specific projects. - Execute and lead groups to execute well designed projects. - Plans and manages the successful implementation of the project deliverables. - Identify and install metrics to evaluate effectiveness of process improvements. - Provide process/system design and optimization ideas. - Partner with the Performance Analytics and Benchmarking group to provide business performance analysis support. - Collaborate with the SOP and Training lines within OPS to ensure appropriate SOPs and Training are in place for all new processes Competencies: - Demonstrated knowledge of clinical research processes and regulatory requirements; ability to gain command of process details. - Expert knowledge of PM/CI practices/principles (e.g. six sigma, lean, etc.) applied within the Pharmaceutical Industry. - Effectively uses a wide range of communication skills - Proven skill in leading matrix teams. Possesses effective prioritization, communication, and influencing skills. - Capable of applying project management and communications skills as well as business process tools. - Demonstrated ability to manage complex projects and cross-functional processes - Able to develop and implement tools/methodologies and improve/enhance process or business related practices - Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for deployment and adoption.JOB REQUIREMENTS:Training & Education Required: - Bachelors level education or equivalent in science or technical discipline - Certification in Lean Six Sigma Black Belt tools and methodologies, Six Sigma Master Black Belt preferred - - Experience with Agile methodology desirable Training & Education Preferred: - PMP certification - Masters level education in science, technical or business based discipline highly desired - Business degree and/or coursework with specific training in process methodologies and tools are desirable. - Training in leadership skills, supervisory skills and change management skills PriorExperience Required: - Previous track record of success in project management in clinical trial execution or drug development background. - Utilized Design for Six Sigma Methodologies in recent project work. - Has implemented projects which influenced business or strategic outcomes. - Experience using statistical software (SAS , Minitab, etc) and various SPC tools (i.e., control charts, process and measurement capability, iNexus). - Ability to build strong global and local networks across functions, lines and zones. - Strong interpersonal skills with a demonstrated ability to interact and influence with many levels of technical and business staff. Excellent analytical and organizational skills are required. The candidate must also possess very good communication skills (both written and verbal). - BS and over 10 years - MS and over 5 years Prior Experience Preferred: - Experience working in a global and multicultural organizations working across national and international boundaries - Has developed and led projects which influenced business or strategic outcomes. - Hands-on managerial/leadership experience. - Thrives in product development and/or fast paced complex operating environment. - A strong working knowledge and understanding of drug development processes, database structures, relational databaseORLJob Requirements
Country: USA, State: New York, City: New York, Company: InVentiv Health.
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