Data Management
Resume:
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WWW.LINKEDIN.COM/PUB/EMMANUEL-LOUIS/59/B58/630/
EMMANUEL LOUIS
Profile
I am a goal driven achiever with great problem solving skills with extensive experience in working in the clinical
research industry. I am able to work and thrive in a challenging working environment by finding innovative
ways to effectively reduce days off a study design timeline or any other task. I bring both the knowledge and
experience of validating an Electronic Data Capturing system and writing Standard Operating Procedures. In
Addition, I helped design standards for clinical specification documents in Study Data Tabulation Model
standards. I have been a part of numerous audits performed by the Federal Drug Administration or by a vendor. I
excel in programming edits in any Electronic Data Capturing system by having a strong background in
programming in multiple programming languages. I have design over 60 simplistic and complex trials. Also, I
have experience and flourish in both working individually or as part of a team.
Experience
Se
pt 2011 - Present Miramar, FL
Comprehensive Clinical
Development/Watson Therapeutics, Inc.
Database Administrator
Familiar with the ExPERT and DataTrak application
Provide a strategy to help build studies faster and more efficient
Program edits (a warning message based on a criterion) in numerous languages
Visual Basic
DataTrak language – Dependencies and Scripts
ExPERT sql (Structured Query Language)
Provide reports from the database to the Data Management Team using Structured Query Language
Convert study data into Study Data Tabulation Model (SDTM) standards using the DataTrak
application
Used Triggers to dynamically build studies within the ExPERT application
Experience in working on Generic as well as First to File studies
Wrote Standard Operating Procedures for my Department
Database Creation SOP
System Administration SOP
Configuration and Release Management SOP
User Account Management SOP
Validate and re-validate an Electronic Data Capture system
Created test specifications
Created test records
Perform unit testing on the Electronic Case Report Forms with valid and invalid data
Develop and Standardize the Edit Check Specification and Database Specification documents to adhere
to SDTM guidelines by leveraging knowledge of clinical protocols
Maintain an overall knowledge of regulatory guidelines, industry standards, and new technologies
Provide document/electronic data capture system specific training to Sponsors or Data Management
Possess working knowledge of GCP/ICH guidelines
Familiar with end of study procedures: Database Lock, Database Freeze, Study Close Out CDs, and
Database unlocking procedures
Identify user groups allowed to access studies within the EDC system
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Knowledge of clinical data and medical terminology
Fundamental working knowledge of Adverse Event (MedDRA) and Medication (WHO-Drug) coding
dictionaries
September 2011 Allied-Barton Security Services
Miami, FL
(Post: Del Monte Fresh Produce Company)
Security Supervisor
Supervised overall site security for Del Monte Fresh Produce Company (DMFP).
Troubleshoot any location issues with DMFP personnel, including collaborating with the Information
Technology (IT) team, to resolve OnGuard Application server connection issues.
Managed a staff of 4 employees.
Maintained staff schedule and vacation requests, while accommodating business needs.
Sustained a cohesive working environment conducive to team building efforts.
Resolved personnel and other work-related issues as needed.
Processed employee payroll.
Recruited and interviewed potential new hires.
Administered work-related exams as required.
Completed administrative tasks (i.e. reports, investigations, etc.).
Education & Skills
Business Administration, Associates of Arts June
2005
Miami Dade College
Information Technology, Bachelor of Science December 2011
Florida International University
*Information Technology/Database courses completed/EDC Experience*
Information Storage and Retrieval Survey of Database Systems
Database Administration Intermediate Java
Java Programming Intro to Unix/Linux Systems
Unix System Administration Computer Operating Systems
Microcomputer Organization Math Concepts for IT
Applied Computer Networking Windows Programming for IT
Website Construction Management
Website Construction Management: Created Java Server pages and JavaBeans. Implemented
personal shopping web page, for users to make purchases and view previously purchased items from
database.
Java Programming: Wrote several programs in Java as related to containers, polymorphism, RTTI,
exceptions, IO, etc.
Visual Basic: Created form applications for users, and connected and wrote database queries for
information within a form.
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Database: Worked with an instance of Microsoft Sql Server 2005, and learned how to put a table into
4th normal form. Knowledge of concepts such as database restoration post disaster, partitioning,
schemas, partitioning function and partitioning schema, splitting window, database snapshot, query
optimization, data mining, data warehouse, spatial data, semi-structured and structured data, indexes,
etc.
UNIX Courses: Responsible for maintaining a virtual UNIX system. Updated the system regularly
with the latest patches, and installed webadmin, MySQL, php, etc. Occasionally scheduled cron jobs to
back up the system, and wrote bash scripts to manipulate files.
E lectronic Data Capture Systems
DataTrak
ExPERT
Skills
SQL, Java, Bash Scripting, Visual Basic, C, PHP, MySQL, Linux
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