Paul K. Davis

Experience

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  Pfizer

  Jan 1998 - Jan 2002

  Senior Systems Analyst

  Managed a highly motivated and talented team of 20 contractors responsible for the design, implementation, and operations of a clinical trial tracking and metrics system providing clinical trial status reporting, financial forecasting, resource management, and dashboards to drug development teams and management. System was deployed to 5 global sites and significantly reduced the amount of time spent by clincial trial teams compiling, formatting, and distributing clinical trial information throughout the organization. Show less

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  Organon Pharmaceuticals

  Jan 2002 - Jan 2004

  Senior Manager

  Variously managed several high performance teams within the Clinical Data Systems and Programming department. Teams managed included the Project Management, Compliance, and Operational Support teams responsible for the implementation, validation, and operational support of all clinical IT systems. Successfully implemented a local validation model for software development, steamlined operational support processes, and implemented a pilot case report form tracking system and an Oracle RDC system. Show less

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  Bristol-Myers Squibb

  Jan 2004 - Jan 2007

  Program Team Informatics Lead

  Performed a change agent role representing Global Development Informatics within a group of phase III drug development teams. Facilitated the adoption of new systems and processes including the rollout of a global remote data collection system, a framework for engaging Clinical Research Organizations for outsourced work, and an extended support process for drug teams preparing for a New Drug Application filing.

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  BLC Consulting Group

  Jan 2007 - Jan 2009

  Program Manager

  Client: Pfizer, Inc.Managed a talented and dedicated team of professionals in the definition, implemention, and operations of a global Identity & Access Management process within an ITIL-aligned shared services organization. Remediated several significant SOX related issues identified by Internal Audit, reduced process non-compliance to less than 1% of all transactions processed, and successfully passed a subsequent Internal Audit review of the new process.

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  Essex Management, LLC

  Sept 2009 - Oct 2011

  Program Manager

  As a consultant to the NCI, provided program management and business analysis expertise to a variety of projects within the Cancer Biomedical Informatics Grid (caBIG®) initiative. • Managed the initiation of a Clinical Data Management System (CDMS) program hosted by the NCI for use by not-for-profit organizations conducting cancer research. Worked closely with NCI employees, a large commercial software vendor, and a variety of potential external users of the system, including NCI-designated cancer centers and cooperative groups, to prepare the CDMS for deployment to the cancer research community;• Led a group of analysts responsible for defining requirements for the clinical trial patient accrual and person/organization directory modules within the NCI’s Clinical Trial Reporting Program (CTRP);• Led a team of external cancer center personnel in the creation of user stories and requirements for a Protocol Lifecycle Tracking (PLT) system to track critical activities and milestones related to the start-up, initiation, conduct, and close-out of a clinical study;• Led a team of Cancer Patient Advocates in the creation of a process model and user stories describing a cancer patient’s journey when interacting with the cancer care process including obtaining a diagnosis, developing a care plan, pursuing a care plan, and pursuing a survivorship plan. Show less

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  Pointmark, LLC

  Oct 2011 - Jan 2015

  Owner

  As a consultant to Verizon Business Solutions, provided program/project management and business analysis expertise in delivering innovative cloud based identity solutions as part of the Verizon Universal Identity Services (UIS) program for the healthcare sector. • Managed the delivery of a cloud-based identity registration user interface for collecting basic 411 information, registering multiple form factors for use in two-factor authentication, NIST Level 3 identity vetting, and issuance of SAFE-compliant digital certificates for ePrescription digital signatures;• Managed the definition and delivery of several innovative solutions for the UIS platform including the concept of cloud-based One Time Password delivery (OTP), mobile device QRCode authentication capabilities, and cloud-based SAFE Biopharma-based digital signatures via Adobe Acrobat. Show less

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  HydrantID

  Jan 2015 - Aug 2015

  Senior Program Director

  HydrantID is an identity and advanced authentication technology company with a focus on public digital certificate issuance, private PKI implementations, and advanced multi-factor authentication solutions. Responsibilities included: • Establishing and managing product and service delivery offerings for internal HydrantID groups and external customers within a defined, efficient, and profitable framework;• Managing external professional service contracts by reviewing proposals, initiating and managing customer engagements;• Partnering with the Internal Solutions team to initiate and manage large customer engagements by establishing objectives, developing requirements, defining timelines and estimating/managing costs. Show less

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  Essex Management, LLC

  Nov 2015 - now

  As a consultant to the Laura and Isaac Perlmutter Cancer Center:• Partnered with the Perlmutter Cancer Center to design and implement em-PACT, a novel approach for managing the process by which a new clinical study is opened to enrollment in order to reduce the time to activate a new study to 100 days or less.• Managed the definition and implementation of processes within the Clinical Trial Operations group supporting the NCI-mandated Clinical Trial Reporting Program (CTRP), annual NCI Cancer Center Support Grant (CCSG), and National Institutes of Health (NIH) ClinicalTrials.gov reporting requirements including trial registration, protocol amendments, accrual reporting, and NCI CCSG Data Tables 1-4. Show less

  • Senior Vice President, Services

    Apr 2023 - now

  • Vice President, Service Management

    Jan 2022 - Apr 2023

  • Director, Business Process Automation

    Apr 2018 - Jan 2022

  • Senior Associate

    Nov 2015 - Apr 2018