Data Management

Kevin John Kerr

***** ****** ******, *********, ** 20853

Phone: 240-***-**** (mobile) ( Email: ******@*********.***

Professional Profile

- Extensive experience in pharmaceutical/biotech research environment

- Strong, comprehensive clinical trial data management abilities

- High level of proficiency in the development and implementation of

clinical database systems, with 8 years of experience in the

application of electronic data capture (EDC) systems

- Expertise in data management process analysis and procedure

development for study life cycle

- Solid experience in managing CRO and internal staff

- Familiarity with cardiovascular, GI, immunization, and oncology

indications

- Substantial personal computer experience

- Reliable verbal and written communication skills

Technology/Systems Skills

EDC systems: in-depth experience with DATATRAK (StudyTrak and eClinical);

working knowledge of DSG eCaselink, Medidata RAVE, Oracle Clinical, Phase

Forward Inform, and Phoenix Data Systems; Paper-based clinical data

management systems: comprehensive experience with MS Access 2003-2007,

Oracle Clinical, and Clintrial (4.3, 4.1, and 3.3); Other clinical data

management systems: experience with medical auto-encoding systems and

familiarity with medical coding dictionaries such as MedDRA, ICD-9, SNOMED,

and WHOART

Other: Microsoft Office; SQL Plus, SAS Viewer, SAS Jump; completed 2007 SAS

Programming I: Essentials course; Adobe Acrobat; Edit Pad Pro; FTP

applications; XML and SGML editing experience; familiarity with HTML;

familiarity with ClinicalTrials.gov and FDA eCTD document management

systems, familiarity with MS Visual Studio

Education

COLLEGE OF WILLIAM AND MARY, Williamsburg, VA

B.A. Sociology, 1978-1982; obtained requisite credits for minor in

English

GPA overall: 3.5; GPA in field: 3.8; Society for Collegiate

Journalists

Employment Experience

DIGITAL INFUZION, INC., Gaithersburg, MD

Data Specialist, August 2010 to Present

- Designs and maintains data collection tool and performs data

collection of clinical trial data at FDA

- Designs and maintains MS Access database and loads retrieved clinical

trial data into database

- Develops and maintains database queries in MS Access to facilitate

data processing

- Integrates and maintains medical coding tool (Cliniclue Autocoder for

SNOMED) in MS Access to facilitate standardization of collected

medical data

- Reviews and updates medical coding data

- Develops and documents data collection and processing procedures

- Provides task lists and progress reports for project management

- Prepares presentation materials and presents progress reports to FDA

team

Major accomplishments: developed and implemented data collection and

database for pilot project containing study level, exclusion criteria,

demographic, and medical history data for 150 clinical trials;

facilitated the identification of medical terms of interest to the

project; established data structure standards and authored data

collection and processing workflow

ALEXANDER STREET PRESS, LLC, Alexandria, VA

Data Processing Specialist, November 2009 to July 2010

- Oversaw the conversion of print and electronic source material for

online access by library customers. Includes processing html, xml and

sgml texts, PDF, and image-based files. Software used: Edit Pad Pro,

Adobe Acrobat, Photoshop, ACDSee Pro, and proprietary systems

- Performed quality assurance on converted material

- Performed project management and vendor management tasks

Major accomplishments: instrumental in restarting and successfully

continuing the Literature Indexing effort with the preferred vendor; was

a main reason for meeting company goals for release of print pages, and

helped to achieve long-awaited Literature material migration to upgraded

platform

MACROGENICS, INC., Rockville, MD

Senior Data Specialist, March 2009 to November 2009

- Developed, executed and oversaw the operational aspects of all data

management activities on assigned clinical studies, including CRF

development and Oracle Clinical database implementation, validation

development, data cleaning, and database closeout activities.

- Acted as liaison to vendors (CROs, laboratories, etc.) to facilitate

completion of study-related data management activities

- Assisted in the development of guidelines and workflows for Data

Management activities.

- Recommended and participated in overall process improvements for data

management.

Major accomplishments: implemented Oracle Clinical production databases

for two clinical trials for diabetes and West Nile virus indications,

respectively

HUMAN GENOME SCIENCES, INC., Rockville, MD

Clinical Data Manager, January 2008 to March 2009

- Performed protocol review, CRF Design, and study set-up activities for

both paper and EDC-based systems, including database design and

validation development

- Performed clinical data review, implementing and tracking query

generation/resolution and quality control of data in compliance with

departmental/project standards

- Wrote CRF completion, data entry and data review guidelines, and

contributed to SOP development

Major accomplishments: developed overall design strategy for pilot EDC

application (Phoenix Data Systems); implemented production databases for

oncology studies

OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, Rockville, MD

Clinical Data Coordinator II and III, September 2001 to January

2008

- Developed, executed and oversaw the operational aspects of all data

management activities for multiple clinical studies, including

Protocol and CRF development. EDC database implementation (DATATRAK),

validation development, data cleaning, and database closeout

activities

- Collaborated with external data collection vendors (EDC, IVRS, lab,

and ECG), and ensured consistency and accuracy of external data

- Played key role in the development of standard edit specifications and

data conventions, as well as department-wide SOPs and related forms

- Principal participant in development of company CDISC/SDTM database

standards

- Assisted in the validation of the medical coding system and worked

with coders to resolve workflow issues and clinical database

discrepancies related to medical coding using MedDRA and WHOART

dictionaries

Major accomplishments:

- Performed lead role in the application of EDC systems for the data

management department regarding clinical database development,

validation, production, and data review; developed and maintained

processes for applying EDC systems to company's standard procedures;

trained other data managers, overseeing their work with regard to EDC

systems application; assisted in training investigative sites and

clinical research associates on use of EDC systems; provided guidance

for all EDC system users

- As lead data manager, oversaw data management activities for 3-year,

global 350-site, 4,000-patient cardiovascular trial completing in

November 2006, including supervision of data management CRO staff of

10 to 12 employees; spearheaded reconciliation efforts for adjudicated

medical event data crucial to successful completion of this study;

received Otsuka Outstanding Achievement Award March 2006

Additional Experience

- Data Reviewer, MIMC/MEDIFACTS, Inc., Rockville, MD, January 2000 to

September 2001

- Data Management Associate, NABI, Inc., Rockville, MD, March 1997 to

January 2000

- Data Preparation Supervisor, WESTAT, Inc., Rockville, MD, June 1992 to

March 1997

- Survey Research Specialist, Social and Scientific Systems, Inc.,

Bethesda, MD, January 1990 to June 1992

- Stock Market Research Analyst, 13D Research, Washington, DC, January

1987 to January 1990

- Title Researcher, Commonwealth Land Title, Washington, DC, July 1985

to January 1987

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