Data Entry
Resume:
Louis Klingler
***** ***** ***** *****, *******, NC 27613
**********@*******.***
SUMMARY
To obtain the position of Clinical Programmer, Clinical Data Management, Clinical Data Analyst, or Quality Assurance and direct internal and outsourced activities to support multiple clinical research projects.
CERTIFICATIONS
Medidata Rave SDBE Certification
SAS 9 Certified
Clinical Trials Research Data Management - Durham Technical Community College
SKILLS
Knowledge of Applications: EDC (Medidata-Rave, Oracle Clinical, InForm), Business Objects XI (BOXI), Medidata Solutions Patient Profile, Tibco SpotFire Professional, J-Review, MS Office Suite (Word, Excel, Visio and PowerPoint), MS Office SharePoint Server, InfoLink, Inform Clinical Application, Rally, Medstat Advantage Suite, SQL Developer, MS Visual SourceSafe, Inform Architect, SAS, SAS Portal, Visual Basic
Operating System Skills: UNIX, Windows/2003/XP, Windows 95/98/2000, Windows NT
Databases: SQL, DB2, Oracle, Sybase, MSSQL
MEMBERSHIPS
Society for Clinical Data Management
Clinical Research Society
THERAPEUTIC AREAS OF EXPERIENCE
Cardiology, Oncology, Respiratory, Gastroenterology, Renal, Neurology, and Infectious Diseases
PROFESSIONAL EXPERIENCE
INC Research – Raleigh, NC 10/2015 – Present
EDC Programmer / SAS Programmer / Quality Control
Program reconciliation of PK, PGx, labs & SAEs Listings.
Utilize primary development tools including Oracle RDC, Oracle Inform, and Medidata Rave.
Enter test data for data entry screens and edit checks into Oracle RDC, Oracle Inform, and Medidata Rave.
Develop Dashboards representing clinical data to help sponsor with visual understanding of their study using Tibco Spotfire, Business Objects XI (BOXI), Medidata Solutions Patient Profile.
Perform SEC’s to the clinical data according to the relevant guidelines.
Supervise Monthly Data Import Deliverables.
PPD – Morrisville, NC 6/2014 – 8/2015
Clinical Programmer Analyst
Created and maintained programs in SAS and Oracle used for data entry, data management, data validation, statistical report generation, and program validation.
Assisted Data Management and Biostatistics with developing tools and techniques for improving process efficiencies.
Communicated effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget.
Docs Global / GSK Consulting – Durham, NC 9/2011 – 6/2014
Clinical Data Associate
Lead data manager for three studies, phases I - IV.
Entered test data for data entry screens and edit checks.
Database lock preparation.
Performed SEC’s to the clinical data according to the relevant guidelines.
Monthly reconciliation of PK, PGx, labs & SAEs.
Developed SQL queries to identify data errors not caught in routine data cleaning.
Created vendor agreements/specifications.
Processed test transfers from vendors and provided feedback on issues with specifications or format.
Ran QC checks on external data to ensure data meets specification requirements.
Modified SAS & VB code to generate & format workbooks of study data for study team review.
Led in the administration effort of Spotfire, allowing GSK to analyze data, using predictive and complex statistical analysis. Researched and implemented the clinical data reports. Created and designed reports that analyzed the results for the data management teams in Oncology, Respiratory, and Infectious Disease.
Wrote and tested SAS Edit Checks for Therapeutic areas Trials.
CONSULTING ASSIGNMENTS 6/2009 – 7/2011
Allscripts – Raleigh, NC
Electronic Healthcare Report Analyst
Supported clinical applications for hospitals and physicians’ offices in the United States.
Responded to requests for assistance from clients experiencing problems with software, hardware, or operating system difficulties.
Thomson Reuters – RTP, NC
Quality Assurance Specialist
Gathered SDLC requirements and prerequisites for documents that were required by the NC State Office of Medicaid Management Information Services.
Wrote Analytic Test Plan to be reviewed by MMIS.
Novella Clinical - RTP, NC
Quality Control Tester
Wrote and executed test scripts, reviewed results and resolved findings in a report.
Assured process compliance with all regulatory and Novella SOPs.
Improved archiving efficiency by implementing and creating internal documentation for WinMerge.
IBM - RTP, NC 5/1995 – 5/2009
Lead Quality Assurance Test Engineer
Researched, composed, and executed test cases. Wrote test scripts for automation testing.
Responsible for performance testing using Apache Bench and runxsltmark from DataPower to backend databases (DB2, Sybase, MSSQL, Oracle) thru ODBC SQL call in a XML wrapper.
Lead tester for service pack releases that were crucial to customer buy-in.
Created on-line documentation notes for internal and external customers.
Created test plans and test models from business requirements to be used by test team.
Point person for solving migration issues.
Authored troubleshooting and installation documents; Trained employees on product.
Contributed to detailed status summary outlining known defects and defect trends.
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