Patrick Young

Experience

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  Covance

  May 1995 - Jul 1997

  Clinical Research Associate

  Monitored the conduct of clinical programs which included investigator site identification, regulatory document review and processing, conducting pre-study, study initiation, interim monitoring, and study close-out visits. Ensured adverse events and serious adverse events were reported appropriately and accurately for assigned sites. Performed investigation product drug accountability and ensured accuracy of site drug accountability logs. Responsible for the on-time submission of site visit reports, confirmation and follow-up letters, and expense reports. Managed regulatory site files and worked with sites to ensure that all essential and regulatory documentation was present and accurate. Assisted in the daily operation of projects including client contact, site management, SAE narrative writing, CRF data review, and query generation. Developed collaborative relationships with investigator and study site staff. Show less

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  Premier Research

  Jul 1997 - Apr 2000

  Managed and monitored the conduct of Phase 3 clinical programs which included developing and maintaining timelines, budgets, and resource allocation of assigned projects; investigator site identification, regulatory document review and processing, conducting pre-study, study initiation, interim monitoring, and study close-out visits. Ensured adverse events and serious adverse events were reported appropriately and accurately for assigned sites. Performed investigation product drug accountability and ensured accuracy of site drug accountability logs. Show less Monitored the conduct of Phase 3 clinical programs which included investigator site identification, regulatory document review and processing, conducting pre-study, study initiation, interim monitoring, and study close-out visits. Ensured adverse events and serious adverse events were reported appropriately and accurately for assigned sites. Performed investigation product drug accountability and ensured accuracy of site drug accountability logs. Responsible for the on-time submission of site visit reports, confirmation and follow-up letters, and expense reports. Managed regulatory site files and worked with sites to ensure that all essential and regulatory documentation was present and accurate. Assisted in the daily operation of projects including client contact, site management, SAE narrative writing, CRF data review, and query generation. Developed collaborative relationships with investigator and study site staff. Show less Monitored the conduct of clinical programs which included investigator site identification, regulatory document review and processing, conducting pre-study, study initiation, interim monitoring, and study close-out visits. Ensured adverse events and serious adverse events were reported appropriately and accurately for assigned sites. Performed investigation product drug accountability and ensured accuracy of site drug accountability logs. Responsible for the on-time submission of site visit reports, confirmation and follow-up letters, and expense reports. Managed regulatory site files and worked with sites to ensure that all essential and regulatory documentation was present and accurate. Assisted in the daily operation of projects including client contact, site management, SAE narrative writing, CRF data review, and query generation. Developed collaborative relationships with investigator and study site staff. Show less

  • Lead Clinical Research Associate

    Jul 1999 - Apr 2000

  • Senior Clinical Research Associate

    Mar 1998 - Jul 1999

  • Clinical Research Associate

    Jul 1997 - Mar 1998
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  Cephalon

  Apr 2000 - Nov 2005

  Responsible for all day-to-day clinical project activities, delegation of work assignments, investigator site identification, regulatory document review and processing, conducting pre-study, study initiation, interim monitoring, and study close-out visits. Assisted in the writing of monitoring/CRF completion guidelines and development of CRFs. Participated in the planning, design, and implementation of research protocols. Presented at investigator and data review meetings. Interfaced with scientific thought leaders, study site medical personnel, regulatory agencies Show less Responsible for all day-to-day clinical project activities, delegation of work assignments, investigator site identification, regulatory document review and processing, conducting pre-study, study initiation, interim monitoring, and study close-out visits. Assisted in the writing of monitoring/CRF completion guidelines and development of CRFs. Participated in the planning, design, and implementation of research protocols. Presented at investigator and data review meetings. Interfaced with scientific thought leaders, study site medical personnel, regulatory agencies Show less Responsible for all day-to-day clinical project activities, delegation of work assignments, investigator site identification, regulatory document review and processing, conducting pre-study, study initiation, interim monitoring, and study close-out visits. Assisted in the writing of monitoring/CRF completion guidelines and development of CRFs. Participated in the planning, design, and implementation of research protocols. Presented at investigator and data review meetings. Interfaced with scientific thought leaders, study site medical personnel, regulatory agencies Show less

  • Associate Director, Clinical Operations

    Jan 2004 - Nov 2005

  • Senior Manager, Clinical Research

    Jan 2002 - Dec 2004

  • Manager, Clinical Research

    Apr 2000 - Dec 2002
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  Shire Pharmaceuticals

  Nov 2005 - Feb 2007

  Clinical Programs Director

  Responsible for the oversight, management, execution and delivery of clinical development programs in support of Shire’s project strategy teams. Responsible for the generation of clinical development plans in collaboration with other research and development functions, Line management responsibility for Clinical Programs staff. Managed financial and budgetary aspects of clinical programs for assigned projects. Responsible for strategic initiatives for process and business improvements.

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  Premier Research

  Feb 2007 - Apr 2013

  Project Management and Clinical Monitoring Executive Director

  Clinical Project Management:Coordinated and chaired Executive Oversight Governance Committee and developed Relationship Management Plan. Performed as primary contact for customer regarding quality performance of project teams, ensuring all critical program items and issues are resolved and escalated appropriately. Provided clinical trial management services through a strategic partnership assignment. Managed the execution of studies and provided vendor/CRO/CRA management and oversight. Tracked performance metrics of studies, reported project status and facilitated weekly interdepartmental project team meetings with customer senior management and vendors. Provided operational cross-functional team management. Promoted accountability within the project teams for the conduct of clinical programs. Performed ongoing evaluation of project progress through the use of company tracking systems, status reports, utilization metrics, and monthly management project review meetings. Clinical Monitoring Services: Directed the Clinical Monitoring Services group within the Clinical Development Services department including the direct supervision and ongoing performance management of CRAs and CRA Line Managers. Oversaw the hiring, development and implementation of the new CRA Employee Orientation training and on-boarding. Managed and tracked CRA utilization metrics across all clinical programs. Assisted in the development of department policies, SOPs, and Working Guidelines and quality control monitoring plans. Performed on-site and off-site quality monitoring assessments for ongoing CRA quality oversight, training and development. Show less

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  Numoda Corporation

  Jul 2013 - Oct 2013

  Senior GC, Project Management
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  Syneos Health

  Oct 2013 - Oct 2020

  Senior Project Director
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  Syneos Health Clinical Solutions

  Oct 2020 - Jul 2021

  Senior Director, BU Operations Management, CNS
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  Syneos Health

  Jul 2021 - now

  Executive Director, Project Delivery, Neuroscience

  - Leads the implementation of global project management systems and processes to increase efficiency. Plans for the efficient allocation of resources within operations through resource management and review of staff utilization- Provides direction of performance improvement, operational efficiencies, and operational excellence by identifying best practices and ideas for innovation and continuous improvement within Project Management- Develops contingency plans and risk mitigation strategies to ensure success of the Project Management Function- Drives project management processes within the Company, using established process modeling techniques. Develops and refine project management processes within the Company, using established process modeling techniques. Reviews and provides input into the development of SOPs and WIs related to any area concerning project management to support new or existing processes. Implements enterprise wide project management systems and tools.- Provides project or program oversight, and ensure the project or studies within a program are conducted to reflect the therapeutic or client specific requirements. Show less