Summary
Overview
Work History
Education
Skills
Affiliations
Presentations and Articles
Timeline
Generic

Lee Walke

Union,KY

Summary

Improve clinical research access and outcomes by harmonizing clinical systems and research processes. Leveraging more than 30 years of progressive experience in clinical development and a passion for learning and innovation.

Overview

33
33
years of professional experience

Work History

Executive Director, ESolutions Architect

Elligo
05.2022 - Current
  • Strategic lead for EHR-enhanced studies, patient recruitment, digital campaigns, website development, and patient travel.

Director, Development, Life Sciences

Veradigm
03.2019 - 05.2022
  • Product Owner for a software platform and research network of EHR users, allowing healthcare practices to participate in Real World, prospective, observational research
  • Market Assessment, Product Design, Inception, and Roadmap
  • Develop partnerships with CROs, Sponsors, and technology providers to provide end-to-end research solutions.

Director, Research and Development

HighPoint Solutions (IQVIA)
05.2018 - 12.2018
  • Launched a US-practice in technology consulting for clinical development
  • Developed an eClinical Roadmap for emerging and mid-tier research sponsors enabling a shift to from full-service contracts to functional service providers (FSPs)
  • Developed a Risk-Based Monitoring Adoption package for emerging and mid-tier pharma.

Owner, Principal

Lee Walke Research Consulting
05.2017 - 05.2018
  • Working for an emerging pharma company, I built their data management department and provided: CRO Oversite, Metrics and Key Risk Indicators, Fit-for-purpose processes, Guidance hiring permanent team members.

Vice President, eClinical/Real World Evidence and Late Phase Research

Medpace
06.2015 - 04.2017
  • Executive with dual responsibilities: Establish and run a Late Phase Research Service and oversee eClinical technology
  • Led business development activities; achieved 21 m USD in sales on a 15M USD target in 2016
  • Oversee all clinical systems: CTMS, EDC, IWRS, eTMF
  • Responsible for in-house software development and partnering with software vendors
  • Lead the specification, development, marketing, and implementation of a next generation EDC system, capable of secure, direct patient contact, sophisticated data integration, advanced reporting, and eSource-ready.

Executive Director, Late Stage Analytics

inVentiv Health Clinical (Syneos)
05.2014 - 06.2015
  • Rebuilt a global Late Stage Analytics department
  • Establish best practices, train and hire staff, secure new business to support growth, renew collaboration with support services and strengthen relationships with long-term clients
  • Served as technology advisor and leader for innovations and new services for Late Stage
  • Managed Health Economics, Statistics, Programming, and establish services for Data Management and Medical Writing.

Senior Director, Biometrics

MAPI (ICON)
11.2008 - 05.2014
  • Devised and executed methods for collecting real-world outcomes and clinical data, performing analytics, and publishing the results
  • Consulted with top-tier pharma companies, emerging biotechs, and payers
  • Built a full-service data management group, a diverse group of statisticians, a medical writing group, and an exceptional team of programmers
  • Collaborate with epidemiologists, medical experts, applications developers, and a diverse group of vendors
  • Led integration of North American Biometrics department with French office
  • Introduced metrics, standards, key performance indicators and accountability, resulting in no rework, and no missed timelines for 4 years in a row
  • Led EDC strategy and dramatically expanded EDC capability, including integrated ePRO (Electronic Patient Reported Outcomes), and EHR integration
  • Re-engineer site payment process and technology; led a multi-disciplinary and international team to develop process and requirements for site reimbursement
  • Developed a drug tracking system tuned for Compassionate Use and Expanded Access programs (EAPs)
  • Hired and coached new and incumbent managers, resulting in 0% voluntary turnover for 3 years
  • Developed Medical Writing Function, wrote SOPs, hired staff
  • Developed an internship program with the University of Kentucky and Eastern Kentucky University for Statistical programmers.

Senior Director, Biometrics

Kendle (Syneos)
05.2007 - 11.2008
  • Oversee Biostatistics, Data Management and Programming for Kendle Offices in Cincinnati, Chicago, Los Angeles, Durham, and Wilmington, NC - 240 employees
  • Accountable for the performance of key global studies, including a pivotal 3400 patient, 12 country EDC study (7 outside of North America/EU)
  • Promote the development and use of standards
  • Develop and implement improved processes
  • Fully accountable for meeting revenue targets (44m USD) and the overall profitability for Biometrics
  • Develop and maintain strategic partnerships with customers.

Director, Quality Management Systems

PRA (ICON)
05.2005 - 05.2007
  • Dual Role - Product Manager for global, enterprise-wide electronic document management system
  • Directed all phases of the project under Systems Development Lifecycle (SDLC) – requirements gathering to go live
  • Documentum-based, with custom functions developed in-house
  • Product Manager for Document Management and Quality Assurance Services in a fully compliant ISO 9000-2001 environment.

Director, Clinical Data Management

PRA (ICON)
01.2004 - 05.2005
  • Centralized and Integrated 135 employee North American Data Management Operations
  • Oversaw Database Programming, globally, including US, EU, Canada and India
  • Lead Adoption of CDISC–based (SDTM and ADaM) standards.

Proposal Director

PRA (ICON)
01.2003 - 01.2004
  • Led proposal team for clinical development proposals – Directed the efforts of business analysts, proposal coordinators, writes, and researchers.

Director, Analysis Programming and Electronic Publishing

PRA (ICON)
06.1997 - 01.2003
  • Progressive management roles rooted in analysis programming activities across the organization
  • Directed SAS and Database programming activity for 22 programmers in Virginia and New Jersey
  • Developed processes, harmonized technology for PRA’s first eNDA, and established electronic publishing group.

Clinical Programmer (Entry Level Through Senior)

PRA (ICON)
06.1990 - 06.1997
  • SAS Programmer supporting analytics and data management
  • Pioneered data integration processes for FDA submissions.

Education

Master of Science in Management Information Systems -

University of Virginia
Charlottesville, VA
05.2001

Bachelor of Arts, Psychology -

University of Virginia
Charlottesville, VA
05.1989

Skills

  • Product Development and Management
  • eClinical (ePRO, EDC, eCOA, IVRS)
  • Risk Based Monitoring (RBM)
  • Regulatory Submissions
  • Data Integration
  • Clinical Data Management
  • Programming and Analytics
  • Electronic Health Records (EHR) for research
  • Decentralized Trials (DCT)
  • Real World Evidence and Data (RWE, RWD)
  • Patient Recruitment
  • Proposal Development
  • Process mapping fit-for-purpose research solutions
  • Stakeholder Relations
  • Budgeting and Financial Management
  • Consulting
  • Financial Management
  • Contract Management
  • Compliance and Regulations
  • Leadership Development

Affiliations

  • Decentralized Trials Research Alliance (DTRA) Leadership committee, and steering committee member.
  • Co-Chair, Cost-Benefit Group, CDISC/FDA eSource Stakeholders’ committee
  • Drug Information Association (DIA)
  • Society for Clinical Data Management (SCDM)
  • International Society For Pharmacoeconomics and Outcomes Research (ISPOR)
  • PHARMASUG, SAS User’s Groups

Presentations and Articles

  • Co -Presenter with François Torche, CEO of CluePoints for three, 3 hour seminars in Risk Based Monitoring titled, 'RISK-BASED MONITORING REVEALED'. This was an in-depth, cased based look at technology and processes for implementing RBM effectively, particularly in a data management setting.
  • Pharmacoeconomic Assessment through Market Approval and Beyond: Theory and Operations - Webinar
  • Addressing Observational Research Challenges by Scrutinizing Conventional Data Management Practices, Society for Clinical Data Management, September 2016
  • A Step-By-Step Path to Collect Data from Electronic Health Records Systems. Summit for Clinical Ops Executives, February, 2014
  • The Use of Electronic Medical Records in Clinical Research, PMR Newsletter, December, 2012
  • A Programming Development Environment for SAS Programs. Southeast SAS Users Group, August 2002
  • An Analysis Programming Process Focused on Data Derivation, Pharmaceutical SAS User’s Group, May, 2001
  • Ensuring the Accuracy of Statistical Reporting: New methods for Quality Control, presented to the Pharmaceutical Manufacturers Association, November, 1998.

Timeline

Executive Director, ESolutions Architect

Elligo
05.2022 - Current

Director, Development, Life Sciences

Veradigm
03.2019 - 05.2022

Director, Research and Development

HighPoint Solutions (IQVIA)
05.2018 - 12.2018

Owner, Principal

Lee Walke Research Consulting
05.2017 - 05.2018

Vice President, eClinical/Real World Evidence and Late Phase Research

Medpace
06.2015 - 04.2017

Executive Director, Late Stage Analytics

inVentiv Health Clinical (Syneos)
05.2014 - 06.2015

Senior Director, Biometrics

MAPI (ICON)
11.2008 - 05.2014

Senior Director, Biometrics

Kendle (Syneos)
05.2007 - 11.2008

Director, Quality Management Systems

PRA (ICON)
05.2005 - 05.2007

Director, Clinical Data Management

PRA (ICON)
01.2004 - 05.2005

Proposal Director

PRA (ICON)
01.2003 - 01.2004

Director, Analysis Programming and Electronic Publishing

PRA (ICON)
06.1997 - 01.2003

Clinical Programmer (Entry Level Through Senior)

PRA (ICON)
06.1990 - 06.1997

Master of Science in Management Information Systems -

University of Virginia

Bachelor of Arts, Psychology -

University of Virginia

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Lee Walke