Kenneth Milstead

Current

• Clinical Data Management Consultant at Infinity Pharmaceuticals
• Principal Consultant at BioBridges, LLC

Past

• Clinical Data Management Consultant at Vertex Pharmaceuticals
• Clinical Data Management Consultant at ArQule
• Clinical Data Management Consultant at Dyax Corp

• Lead Clinical Data Manager at Outcome Sciences, Inc.
• Clinical Data Management Consultant at Multiple Clients/Organizations
• Clinical Database Manager at Columbia Laboratories
• Clinical Data Associate at Fujisawa USA
• Clinical Data Coordinator at Tulane University
• Clinical Research Associate at Tulane University

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Education

• The University of Texas Health Science Center at Houston
• Tulane University

Recommended

5 people have recommended Kenneth

Connections

156 connections

Industry

Pharmaceuticals

Kenneth Milstead’s Summary

I am an experienced Clinical Data Management consultant with 20 years of clinical research experience (including 17 years in phase I-IV clinical trials) in the US, Canada, and Europe.

I have extensive Clinical Data Management experience in both sponsor and Clinical Research Organization (CRO) environments. I have worked on studies in a wide range of indications in the pharmaceutical/biotech/device industries and in academia. During my career, I have been involved with the complete clinical research process (protocol development to approval), including post-marketing research and patient registries.

Much of my consulting work has involved creating or supporting new Clinical Data Management groups in small to mid-sized companies. I have also assisted clients in meeting particular challenges in their clinical development process, including:

- assisting with client's first submission to FDA or other regulatory agencies,
- locking databases that face particular challenges, and
- managing and coordinating the work of CROs and other vendors.

My knowledge of SAS programming, quality assurance, computer validation practices, pharmacovigilance, epidemiology, and clinical trials monitoring provides a framework that is valuable in working with and managing cross-functional teams.

I have experience both as a telecommuter and as a manager of remote employees and teams. Other strengths include strong written and verbal communication skills and computer/technical expertise.

Kenneth Milstead’s Specialties:

Clinical Data Management, Validation, 21 CFR Part 11, SAS Programming, Clinical Trials, Patient Registries, Post-marketing Research, Epidemiology, MedDRA, WHO-DRUG, Case Report Form Design and Standardization, Clinical Trials/Data Management Training, SAE Reconciliation, Technical Writing, Electronic Data Capture, EDC, SQL, SPSS

Kenneth Milstead’s Experience

• Clinical Data Management Consultant

  Infinity Pharmaceuticals

  (Privately Held; Information Technology and Services industry)

  March 2009 — Present (5 months)

• Principal Consultant

  BioBridges, LLC

  (Privately Held; Pharmaceuticals industry)

  August 2007 — Present (2 years)

  Provided Clinical Data Management consulting services to BioBridges clients, including Dyax Corp, Vertex Pharmaceuticals, Infinity Pharmaceuticals, and ArQule.

• Clinical Data Management Consultant

  Vertex Pharmaceuticals

  (Public Company; VRTX; Pharmaceuticals industry)

  September 2008 — April 2009 (8 months)

  Managed CRO data management activities for three outsourced European phase I clinical trials.

• Clinical Data Management Consultant

  ArQule

  (Public Company; ARQL; Biotechnology industry)

  May 2008 — August 2008 (4 months)

  Managed CRO data management activities for outsourced clinical trials.
  
  Provided Clinical Data Management consulting expertise to ArQule management.

• Clinical Data Management Consultant

  Dyax Corp

  (Pharmaceuticals industry)

  August 2007 — June 2008 (11 months)

• Lead Clinical Data Manager

  Outcome Sciences, Inc.

  (Privately Held; Computer Software industry)

  July 2006 — August 2007 (1 year 2 months)

  Started and managed the Clinical Data Management team at Outcome, including Clinical Data Managers, Clinical Research Associates (Monitors), and contract SAS Programmers.
  
  Provided input to management team and to Business Development regarding data management aspects of project bids and existing contracts.

• Clinical Data Management Consultant

  Multiple Clients/Organizations

  (Research industry)

  June 1998 — July 2006 (8 years 2 months)

  Provided consulting services in clinical data management for various clients in the pharmaceutical, biotechnology, and device industries, as well as in academia.
  
  Projects included data management, statistical analysis, SAS programming, computer validation, writing of SOPs, systems analysis, and training.

• Clinical Database Manager

  Columbia Laboratories

  (Public Company; 11-50 employees; Pharmaceuticals industry)

  September 1996 — May 1998 (1 year 9 months)

• Clinical Data Associate

  Fujisawa USA

  (Public Company; 201-500 employees; Pharmaceuticals industry)

  July 1993 — March 1995 (1 year 9 months)

• Clinical Data Coordinator

  Tulane University

  (Educational Institution; 1001-5000 employees; Higher Education industry)

  December 1991 — July 1993 (1 year 8 months)

  Coordinated all Quality Assurance activities for the Tulane-LSU AIDS Clinical Trials Unit.

• Clinical Research Associate

  Tulane University

  (Educational Institution; 1001-5000 employees; Higher Education industry)

  April 1991 — November 1991 (8 months)

  Performed data management activities for the Tulane-LSU AIDS Clinical Trials Unit.

Kenneth Milstead’s Education

• The University of Texas Health Science Center at Houston

  MS , Public Health (Epidemiology) , 1988 — 1993

• Tulane University

  BA , Psychology/Political Science , 1984 — 1988

Additional Information

Kenneth Milstead’s Interests:

Clinical Trials Data Management, SAS Programming, Application of Technology in Clinical Research and Public Health, New Orleans, Travel, Providence, Rhode Island, Boston, Epidemiology, Pharmacoepidemiology, Pharmacoeconomics, Health Policy

Kenneth Milstead’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• new ventures
• job inquiries
• expertise requests
• business deals
• reference requests
• getting back in touch