Data Management
Resume:
TONY W. GUITEAU
**** ******* ***, ******, ** ****8 267-
PROFILE
Dynamic Neuroscience graduate offering knowledgeable and professional
experience in dealing various scientific areas. I am highly
competent when dealing with, employees, the public, or managers in
fast-paced, busy, and fluid environments. Confident and poised in
interactions with individuals at all levels, in addition to being
detail-oriented and resourceful in completing projects.
EDUCATION
KING'S COLLEGE, Wilkes-Barre, PA
BS in Neuroscience & Minor-Psychology
Graduation May 2004
PROFESSIONAL AFFILIATIONS
Society for Clinical Data Management (SCDM) (2008 - Present)
PHARMACEUTICAL TRAINING PROGRAMS
. SDTM Theory & Application (CDISC) (2008)
. Management Essential
(2008)
. Investigating CDM's Present at Investigator Meetings
(2008)
. Project Management in Clinical Data Management (2008)
. Data Management Practices in Cancer Clinical Trail
(2008)
WORK EXPERIENCE
Johnson & Johnson Inc. - US TECH SOULTIONS (Feb
2010 to present)
Clinical Data Manager III
. Development of the data specifications and eCRF design, including
leading the review meeting
. User Acceptance Testing of eCRF and other tools
. Development of the Data Management Plan
. Lead cross-functional review meetings for the data specifications,
eCRF design and Data Management Plan
. Reconcile data streams - such as electronic data transfers
. Perform SAE reconciliations
. Interact with ESP performing data management activities as appropriate
. Ensuring that study database is appropriately cleaned in accordance
with agreed upon data management plan
BioClinica (Formally PHOENIX DATA SYSTEMS) (Apr
2008 to Feb 2010)
Clinical Data Manager
. Managing clinical data reviewers for each assigned data management
project
. Creation of client specific data management plans and CRF completion
guidelines
. Developing project specific edit check specifications
. Carrying out data management UAT prior to release to the customer
. Working in conjunction with study team in developing forms package for
use in the development of the study, in addition to ensuring the
dictionary is CDISC compliance
. In conjunction with reports programmers, develops project specific
reports for metrics and database cleaning
. Conducts manual data review and medical coding for data management
customers
. Ensuring that study database is appropriately cleaned in accordance
with agreed upon data management plan
Therapeutic Area: Oncology (Phase II/III)
OCTAGON RESEARCH SOLUTIONS Inc - UNITED HEALTH GROUP (Jun 2007 to Apr 2008)
Clinical Reviewer
o Conducting second level review of CRF.
o Following; clinically consistent listing of patient's medical history,
medical terminologies, and medication including: proper dosage, and
appropriate indications.
o Determination of excluded medications.
o Review Case Report Form (CRF) data for completeness, accuracy and
consistency
o Resolve data discrepancies (Edit Checks); as appropriate, apply level
I corrections to CRFs; generate and resolve (as appropriate) data
queries
o Perform manual review and monitoring
Therapeutic Area: Oncology (Phase II)
Therapeutic Area: Infectious disease (Phase III)
Therapeutic Area: Respiratory (Phase III)
ICON CLINICAL RESEARCH (Aug
2006 to Jun 2007)
Clinical Data Coordinator
. Review Case Report Form (CRF) data for completeness, accuracy and
consistency.
. Resolve data discrepancies (Edit Checks); as appropriate, apply level
I corrections to CRFs; generate and resolve (as appropriate) data
queries.
. Update/correct/review data in the clinical databases based on resolved
data queries.
. Process laboratory loading validations reports.
. Perform initial subsidiary data review activities.
. Complete all quality control measures necessary for finalization of
the database and any related material to the sponsor.
. Perform manual review and monitoring.
Therapeutic Area: Oncology (Phase II)
Therapeutic Area: Musculoskeletal (Phase II)
MERCK & Co, Inc., Pa - KELLY SCIENTIFIC RESOURCES (Nov 2005 to Aug 2006)
Clinical Data Analyst / Co Project Lead
Clinical Operations - Global Clinical Data Management Operations
. Communicating with the Data operation Lead regarding progress reports,
escalation issues, and resourcing.
. Monitoring CRF keying backlog, mentoring protocol specific to new
staff / assigning tasks.
. Review Case Report Form (CRF) data for completeness, accuracy and
consistency.
. Resolve data discrepancies; as appropriate, apply level I corrections
to CRFs; generate and resolve (as appropriate) data queries.
. Update/correct/review data in the clinical databases based on resolved
data queries.
. Process laboratory loading validations reports.
. Perform initial subsidiary data review activities.
. Manage Discrepancy Notification Form (DNF's) from multiple sources.
. Perform subsidiary medical review and monitoring.
Therapeutic Area: Infectious disease (Phase II/III)
Therapeutic Area: Musculoskeletal (Phase II)
H.J HEINZ C.O L.P, KING of PRUSSIA
(Aug 2005 to Nov 2005)
Quality Assurance / Compliance Coordinator
. Executed necessary laboratory procedures on soups; salt test using
Chloride Analyzer (926); Viscosity test using Brookfield and Bostwick
Viscometer; ph;
. Knowledge in tasting various soups for Appearance, Color, Texture, and
Flavor; Responsible for inspection Production documentation accuracy.
. Work in alliance with USDA to ensure compliance with government
regulations.
. Protects Products safety and quality by placing soup on Quality Holds,
reconditioning and or dumping raw materials that may pose a threat to
the public.
. Perform Pre-operational inspections on equipment sanitation to make
sure company has adequate start-up times.
. Conduct audits pertaining to problem areas in the plant to prevent
noncompliance.
PSC ENVIRONMENTAL SERVICES
Environmental/Lab pack Chemist
(July 2004 to Aug 2005)
* Identifying and classifying hazardous materials according to EPA and
Dot regulations while on client site to determine the most non-
detrimental and cost-effective consolidation and packaging method.
* Inspecting contents of hazardous material containers to determine
chemical designation and generating hazardous waste manifests for
Resource Conservation and Recovery Act (RCRA) compliance, which allows
state departments to track the location of hazardous material through
the lifecycle (Cradle to Grave).
Service work at Hahneman University Hospital & Hershey Medical Center
* Conducting safety inspections, which ensure the hospital's compliance
with health care industry safety standards. This includes the
inspections of fire towers, hallway clearance, etc.
* Utilizing air-monitoring equipment to determine the presence or
absence or air-borne pathogen and hazardous gas concentrations.
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