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Oracle Clinical Management Systems, Senior Consultant

Locations: USA, India


Career Objective: Oracle Partner For Life
Specialization: Oracle Clinical Database OPA & RDC v3.1-4.5.3 Applications, Deve
loper, Senior Data Manager & Medical Laboratory Technologist
Technology Section: Oracle Clinical v3.1-4.53, RDCv4x, TMSv4.6 (Thesaurus Manage
ment Systems), PL/SQL programming, Lab Batch Loading, Database Startup and Lock,
CRF Part 11 Electronic Signatures, Oracle Discoverer, Oracle Integrated Review,
Microsoft Access, Microsoft Excel, Oracle DBA 10g training, Oracle Clinical Tra
iner, MEdDRA, COSTART, WhoDRUG applications, Microsoft Project, Microsoft Word,
Cardiff Teleform v4.1, IQ, OQ System Validations, Experience with SQL Plus(r), S
AS(r) Viewer, Windows, Unix, Linux, Java interfaces.
Professional Summary:
Oracle Clinical Developer duties in Design/Create/Validate clinical trial studie
s in conjunction with the Oracle Clinical Development Teams....... Perform Data
Objects' Configuration and Validation.... Archive/absolutions of pre-existing Gl
ib Data Objects, New Objects Creation, Validation Documentation, and the delinea
tion of Procedure Requirements. Liasion with client's various sponsors' Data Man
agers to discuss/negotiate/manage electronic data submissions of Clinical Data f
rom the sponsor back to the client...
Seventeen+ Total years of experience in Clinical study drug trials databases wit
hin Clinical Research Organizations and pharmaceutical companies in a Oracle Cli
nical RDC and PL/SQL Environment:
* Twelve+ years of Oracle Clinical (r)RDC v3.1- 4.53 experience.
* Eleven years End User Training Oracle Clinical v3.1-4.5.3 Information Technol
ogy students, Senior Data Managers, Research Nurses, Clinical Research Assistant
s, Clinical Data Managers, Clinical Data Coordinators.
* Six+ years of experience in Oracle Clinical OPA and RDC Classic and PDF devel
opment as Global Librarian/Developer, SQL Plus & PL/SQL programming, TMS, and AE
Rs data management.
* Two+ years in Oracle DBA support services including migrations, lab mapping,
and securities.
* Extensive exposure in clinical trials (Phases I, II, IIa, IIb, and III) data
management and database setup/design in Osteology (Regenerative Medicine), Oncol
ogy, Vaccines, Cardiac devices & Radiological imaging, Asthma, CNS & Depression,
Respiratory, and Gastroenterology.
* Four years of Financial Data Management Training Specialists in data collecti
ons efforts in BBN CLINTRIALS v.3.3.
* 10+ years of experience in laboratory Bench testing in Microbiology, Special
& Organic Chemistry, Toxicology, Narcotics Class II testing with GCMS confirmati
on.
Professional Experience Summary: CONTRACTS
* Icon Technical Group, Inc., Roseland, New Jersey, Contract May 8, 2010 - June
12, 2010
Oracle Pharmaceutical Applications & Oracle Accelerate: RapidLive v.4.5.3,
Oracle Clinical Senior Consultant. At client's site build OC databases, train en
try level OC programmers and Information Technology graduates in Oracle Clinical
/RDC Development. Train Clinical Data Managers in case report form annotations,
best practice clinical trials management, RDC & RDC discrepancy management, CDIS
C standards, and in batch file loading into Oracle Clinical.
* ATRM (Advanced Technologies and Regenerative Medicine) LLC Raynham, Mass., af
filiate of Johnson & Johnson, Inc. Contract December 2009 - February 2010
Oracle Clinical v.4.5.1, Senior Consultant
Data management discrepancy cleanup services, Database Closeouts, Work in Fast P
aced environment. Work on site and provide support for studies in Oracle Clinica
l v4.51.
Business & Decision Wayne, PA November 2008 - April 2009
Senior Oracle Clinical Management System Consultant
* Database builds and creation of edit checks and derivations for validation of
clinical trials in radiological imaging studies in Oracle Clinical v4.52
* Led Oracle RDC v4.52 training to 50 on-site clients and remote end-users, spe
cifically in data management processes. Wrote core operating procedures for clin
ical data entry, discrepancy management, and Oracle Clinical (r)RDC work instruc
tions for data entry and discrepancy management in Life Sciences at client site.
* Assist in upgrade and documentation for Oracle Clinical RDC 4.5.3.
Aeras Global TB Vaccine Foundation Rockville, MD Contract July 2008 - October 20
08
Oracle Clinical Data Manager
* Responsible for data entry and discrepancy training and data management and d
ata entry personnel.
* Responsible for PL/SQL edit checks and complete database build in Oracle Clin
ical/ RDC v4.5.2.
* TMS discrepancy management performance and training.
Technical Resources International, Inc. Bethesda, MD: Perm June 2006 - July 2008
Oracle Clinical Senior Data Manager
* Database builds and creation of edit checks and derivations for validation of
clinical trials in radiological imaging studies in Oracle Clinical OPA and RDC
v4.51.
* Trained data managers, CRAs, and various personnel as instructed on Oracle Cl
inical (r) RDC v4.5.1, Database start-up and lock.
* Oracle DBA backup duties up to and including database security: creating and
maintaining database users, installation of Oracle software, and User Acceptance
Testing.
* Interfaced with the clinical research teams to understand and gather protocol
requirements by specifying schema, eCRFs, and treatment cycles in the database
design for trial Phase I & II.
* Planned, analyzed, and coordinated clinical trials research databases in Orac
le Clinical RDC for studies performed at the National Institute of Drug Abuse (N
IDA), and Oracle(r) for the Center for Disease Control (CDC) and other governmen
t entities.
* Wrote training manuals in all areas of data management including data entry,
data cleanup, AE, SAE coding and reconciliation in WhoDRUG, MedDRA.
Harris Orkand Technical Services Corp., Bethesda MD. April 2004 - June 2006
Oracle Clinical Data Analyst
* Trained site and remote clinical teams in Oracle Clinical (r)RDC v.4.5.0 data
entry, discrepancy cleanup.
* Interface with clinical teams in Oncology and HIV research
* Database builds in Oracle Clinical RDC v4.5.1 in Bioinformatics department co
ntracted to NIH, NAVY, Research Institute, and the Cancer Therapy Evaluation Pro
gram (CTEP) Bethesda, Maryland.
* Design, testing, and implementation of common data elements and electronic ca
se report forms in accordance with customized Oracle Clinical (r)RDC program val
idation systems for NCI.
* Assisted in the implementation of new technologies, and Oracle Clinical (r)RD
C customs reports.
* Wrote core operating procedures for data entry, discrepancy management, and O
racle Clinical (r)RDC v4.5.0 work instructions, Database start-up and lock.
* Assist in data migration technology, laboratory mapping and database designs.
Medifacts International February 2003 - April 2004
Senior Clinical Data Analyst
* Trained CDM and RNs in discrepancy management processes.
* Wrote, developed, and tested data validations in the development of research
databases in Oracle Clinical (r)RDC v 4.5.0 in Phase II cardiovascular study.
Laboratory Corporation of America February 2002 - February 2003
Medical Technologist II
* Performed biomedical assays in the Special Chemistry Department including PRE
GNANCY STAT, HPLC, reagent prep, result entry.
Quintiles, Inc. August 1998* - January 2002
Senior Clinical Data Coordinator
* Performed data validations on CNS, Asthma, and Cardiovascular Phase II & III
studies in Oracle Clinical RDC v3.1.0-3.5.0 interfaced with QMS and CTMS systems
. Coding in COSTART application.
* Query resolution, database updates, trained junior data coordinators, and ass
igned data entry tasks.
* Generated data entry and validation status reports as needed, database start-
up and lock.
*Other work experience prior to this date is Bench Laboratory testing and more c
linical data management from 1985 to 1998.
Education/Certifications/Training:
* Masters in Information Systems, Strayer Univ., Rockville, MD, progress June 2
011.
* Bachelor of Science, Biology/Chemistry North Carolina at Central 1984...
* Oracle Clinical Developer Training, Dataceutics, Inc., Pottstown, Massachuset
ts
* Certification Oracle 10g OCA Oracle University Boot Camp Bushkill Falls, PA,
progress 2010.
Awards:
* UNC at Chapel Hill Pre-Medical Scholarship recipient 1985
* Harris Outstanding Employee of the Month 2004
* Individual contribution to NC-11 Contract at NIH, Bethesda, Maryland.
Pride Awards
Technical Resources International Performance Bonus 2006
Business and Decision Performance Bonus 2009
PROFESSIONAL Members Associations:
* Oracle Clinical User Group
* Society for Clinical Data Management
* BDPA: Information Technology Thought Leaders
* DIA non-sponsored member
* CDISC non-sponsored member