Since 2008, Lee Walke has been working in Mapi - Real World Evidence situated 260, 260. This expert is a high-skilled Senior Director, Biometrics with over 17 years of work experience. According to Lee's resume and work profile, the professional has worked at more than seven companies with numerous backgrounds and got different skills. Lee attended school at the University of Virginia from 2000 to 2001. Lee Walke can be found in Hamilton, Kentucky – where this professional is currently located. You can search for the professional's email address and phone number. We can also provide you with detailed contact information upon request.
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Leigh Walke
Last updated Jun 02, 2024
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Work History
Senior Director, Biometrics
Lexington, Kentucky
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 biotechs...
from Nov 2008
Director, Quality Management Systems
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 development pr...
Mar 2006 — May 2007
Director, Global Clinical Data Management
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 Clinphone E...
Nov 2004 — Mar 2006
Proposal Director
Directed development of proposals for Clinical Development services, ranging from Regulatory submissions, Phase I - IV, including all services offered by the CRO.
Lead Strategic discussions ...
Sep 2003 — Nov 2004
Director, Analysis and Reporting
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 Jersey ...
Nov 1999 — Sep 2003
Analysis Programmer/Clinical Programmer
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 code...
Jun 1990 — Nov 1998
Education
2000 — 2001
1985 — 1989
Occupations
Executive
Director
Senior Director
Operations Manager
Senior Manager
Skills
Clinical Trials
Edc
Clinical Data Management
Clinical Development
Cro
Gcp
Sas
Pharmaceutical Industry
Data Management
Program Management
Sas Programming
Clinical Research
Team Building
Cro Management
Regulatory Submissions
Ctms
Electronic Data Capture
Quality Management
Biotechnology
Sop
Medical Writing
Management
Clinical Study Design
Project Management
Regulatory Affairs
Analysis
Enterprise Systems Implementation
Ich Gcp
Leadership
Validation
Data Analysis
Analytics
Cross Functional Team Leadership
Proposal Writing
Sdlc
21 Cfr Part 11
Strategy
Training
Statistical Programming
Change Management
Clinical Monitoring
Integration
Fda
Sdtm
Programming Management
Statistics
Biostatistics
Software Development Life Cycle