Quality Assurance Manager
Resume:
Frederick W.P. Gibbs
Bedford, NH 03110
********@*******.***
SUMMARY OF EXPERIENCE:
I have experience in clinical trials, from database design, creation, and
management through CRF annotations and data entry, database validation,
project management, ending with FDA submission packets.
COMPUTER SKILLS:
* MS Windows * Linux * Unix * MS Office
* SYSTAT * SAS (v. 8) * SPSSPC+ *
Visio
* HTML * FileMaker Pro * DreamWeaver *
InfoMaker
* Adobe Illustrator * FrameMaker * PageMaker
* Quark
* Adobe Acrobat * Crystal Reports * Oracle Clinical
* ClinTrial
RELEVANT EXPERIENCE:
Whipple Hill Communications, Bedford, NH, October 2008 - April 2009.
Jr. Network Administrator
* Help desk activities
* Document writer
* Server maintenance and management
* Worked on integral virtualization projects
* Set-up new users hardware and software
* Managed intranet and Internet usage
* Managed security cameras and reviewed images daily for sign-in
discrepancies
Intergrated Health Care Information Systems (a division of Ingenix),
Londonderry, NH, June 2006 - October 2008
IS Business Analyst II
* Liaison duties between programmers and business customers
* Document writer and process coordinator for the Implementation Team
* Worked with managing software implementation from office as well as
customer site
* Assisted and maintained all implementation change logs as well as data
extract dictionary client-specific customizations
* Managed WebEx conferences during initial contact with potential
customers, providing them with feedback from their initial data
specifications
Community Services Council of New Hampshire, Concord, NH, July 2005 - June
2006.
HMIS Program Coordinator (Grant-sponsored position)
* Coordinating state-wide Homeless Management Information System
implementation
* Training area agencies participating in HMIS (HUD-mandated for funded
agencies)
The New Hampshire Institute of Art, Manchester, NH, July 2004 - Present.
Adjunct Instructor: English, Psychology
* Teach college-level liberal arts courses
* Monitor and assist in student advisement
Sepracor Pharmaceuticals, Marlborough, MA, June 2000 - July 2005.
Clinical Data Manager
* Quality assurance and database design/integrity, creation and maintenance
* Case report form design
* SAS data set merges, review, and some basic programming
* Protocol review and editing
* Discrepancy resolution, query reporting and writing,
* Maintaining study-specific metrics/logistical operations
* Third-party vendor mana
gement/inventory management
* Investigator meeting presentations
(Company had massive layoff in April 2002 due to failing drug market; I
left to avoid the ensuing unemployment)
PAREXEL International Corporation, Waltham, Massachusetts, June 1997 -
February 2002.
Clinical Data Manager.
* Clinical data management
* International logistical support for trial materials/inventory support
* Writing edit checks, validation checks and database queries
* As a primary for several studies, I managed a small team of junior data
managers and acted as a liaison and QA manager between sponsoring company
and PAREXEL.
* Lab Lead working with third-party vendor lab data from LIMS system and
converting into Excel spreadsheet for easy query use
* Study report generation and RFP reviews using Crystal Reports and SQLAsst
* Assisted with protocol development and amendments, case report form
design using Frame Maker and Quark.
* I was part of the quality assurance group for my team and reviewed all
outgoing reports
* Performed internal audits on colleagues' trials with company QA director.
(Left company to become more involved in actual biotechnology industry
instead of working for outsourcing company)
*** From 1989 until 1997, I worked as a clinical social worker in hospital,
clinic and hospice settings. My areas of focus were on working with the
chronic mentally ill, forensic mental health issues, the homeless mentally
ill and with AIDS patients. I assisted in teaching graduate students about
mental health issues, stigma and AIDS intervention/prevention. I mention
this only as support of my healthcare industry experience and understanding
of it both from a practitioner's as well as from as researcher's point of
view.
EDUCATION:
* Case Western Reserve University, Cleveland, Ohio, M.S.S.A., Adult Mental
Health Practice and Psychopathology, 1995.
* The University of Akron, Akron, Ohio, B.A., Social Work, 1992.
ORGANIZATIONS:
* Oracle Clinical Users Group
* Association of Computing Machinery
* International Webmasters Association
* American Association for the Advancement of Science
* Project Gutenberg volunteer editor
* US Army veteran
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