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Work Background
Dermod Wood Associates LLCPrincipal
Mar. 2009* Consulting and training for small professional service firms in the area of project management and virtual teams.
* Apps developer iPhone, iPad and Android using Titanium and HTML5 (HTML, CSS, Javascript, jQuery, SQLite) for http://Globish.com.
Fortune Builders Chapter of BNIBS Artist
Jan. 2015 - Dec. 2015
Fortune Builders Chapter of BNIBS Artist
Jan. 2015 - Dec. 2015
RadPharm Core Imaging LaboratoryIT Project Manager
Jan. 2007 - Feb. 2009Managing the business requirements of five departments and the modification and integration of three legacy systems used in the evaluation of radiographic images for clinical trials. Automated the manual process of transmitting the evaluation data from the read stations to Oracle Clinical for automated response assessments.
Daichi-Sankyo Pharmaceutical Development Inc.Project Manager / Validation Lead
Jan. 2006 - Dec. 2007Managed the implementation and validation of a Documentum 4.3 installation for electronic submissions for Daichi-Sankyo.
Eisai Medical ResearchIT Quality Manager
Jan. 2005 - Dec. 2006• Managed the implementation and compliance of FDA-regulated IT systems including mplementation and validation of a new Global Clinical Database Management System (GCDMS) which integrated Clintrial, Integic CRF Work Manager, iReview, dsNavigator, Crystal Reports and Citrix. • Brought SOPs, operating manuals and guidelines for computer system qualification and validation in line with corporate policies and developed a risk-based IT validation and CFR 21 Part 11 compliance strategy.
• Managed the remediation of gaps in the existing state of IT compliance for GCP systems and the qualified network.
Taro PharmaceuticalManager of Global Computer Validation
Jan. 2002 - Dec. 2004• Incorporated the validation staff in the US, Israel, Canada and Ireland into an integrated global IT validation group with common standards and procedures. • Managed and approved validation projects in US, and also acted as primary technical resource for Regulatory and Clinical R&D, coordinating task forces for selection and procurement of regulated systems and software.
• Managed implementation and validation of various in-house IT projects.
University of Maryland University CollegeAdjunct Prof DM Program
Jan. 2001 - Dec. 2004
Dermod Wood AssociatesPrincipal
Jan. 1995 - Dec. 2002• Consultant with the VA Cooperative Study Program, West Haven, CT on a 4-year Phase III clinical trial of a shingles vaccine (Zostervax) developed by Merck & Co., Inc. Each of the 38,000 subjects at 20 hospital sites had to be actively followed up on a monthly basis for a three-year period • Researched and recommended an automated telephone response system (IVRS) and developed a 4-line pilot project which was deployed as a 24-channel T-1 based system. The IVRS administered a monthly questionnaire to subjects and notified sites of irregularities by automated fax. The system is still in use for post-marketing studies. • Saved an estimated $1.5 million in reduced labor costs for manual follow-up by and enabled very high subject retention rates, further reducing the duration and cost of the study.
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