Lee W.

Executive with 30+ years experience in Clinical Development, specializing in Clinical Data Management

United States of America
English

Thirty+ Years working in clinical development in post-clinical work: System Development and Deployment Clinical Data Management, Programming, Regulatory Submissions, Project Management, and Solution D...see more

  • Healthcare
  • Biotech, Pharma & Life Sciences
  • C-Level & Leadership
  • Quality

425

/hr
  • Pre-vetted expert
  • Confirmed hourly rate
  • Available on short notice

Experience

Executive Director, eSolutions Architect

Elligo Health Research
7 months
Current position
May 2022 - Present
Helping connect healthcare experts with the best research technologies and infrastructure.

Director, Development, Life Sciences

Veradigm®
3 years
Apr 2019 - May 2022
Product Director of StudySource, a research software platform that works with with a medical practice's electronic health record system. This enables medical practices to connect to r...see more

Director, R&D

HighPoint Solutions
1 year
Apr 2018 - Apr 2019
HighPoint, an IQVIA company, gives life sciences and healthcare companies the business technology and strategic planning to go from molecule to market - and beyond. Our industry vetera...see more

Vice President, Real World Evidence and Late Phase Research

Medpace
2 years
Jun 2015 - Apr 2017
Design and implement custom solutions for sponsors of drug and medical device research, particularly in observational, post-marketing, and real-world environments. Develop new and uniq...see more

Executive Director, Late Stage Analytics

inVentiv Health Clinical
1 year
May 2014 - May 2015
Oversaw Global Statistics, Programming, Data Management, HEOR, and Medical Writing for Late-Stage Research, both interventional and observational.

Senior Director, Biometrics

Mapi - Real World Evidence
5 years
Nov 2008 - May 2014
Devise and execute methods for collecting real-world outcomes and clinical data, performing analytics, and publishing the results. Consult with top-tier Pharma companies, emerging bio...see more

Senior Director, Biometrics

Kendle
1 year
May 2007 - Oct 2008
Directed North American Clinical Data Management, Programming, and Biostatistics, in 5 offices.

Director, Quality Management Systems

PRA International
1 year
Mar 2006 - May 2007
Program Leader for an enterprise document management system based on Documentum. (PRA eTMF 2.0) Conducted formal requirements gathering with a global team of diverse clinical developme...see more

Director, Global Clinical Data Management

PRA International
1 year
Nov 2004 - Mar 2006
Directed a 135-person Clinical Data Management operation. Centralized North American Operation, and participated in implementation of hosted EDC system, base on Datalabs XC (Now Clinph...see more

Proposal Director

PRA International
1 year
Sep 2003 - Nov 2004
Directed development of proposals for Clinical Development services, ranging from Regulatory submissions, Phase I - IV, including all services offered by the CRO. Lead Strategic discus...see more

Director, Analysis and Reporting

PRA International
4 years
Nov 1999 - Sep 2003
Directed SAS programming, and electronic publishing in support of clinical trial reporting. Provided program management for eNDA and traditional NDA submissions. Managed Staff in New J...see more

Analysis Programmer/Clinical Programmer

PRA International
8 years
Jun 1990 - Nov 1998
SAS programmer for Clinical Trials work. Made Tables, Graphs, Patient Profiles, Databases, the usual. Developed data integration methods for ISS/ISE submissions, wrote code that wrote...see more

Industries, roles and expertise

Industry experience

  • Healthcare
  • Biotech, Pharma & Life Sciences

Role experience

  • C-Level & Leadership
  • Quality

Expertise

  • Clinical Data Management
  • Clinical Trials
  • Clinical Research
  • Project Management
  • Quality Management
  • Biotechnology
  • Program Management