Data Design

Yuri Marunich

****.********@*****.*** / 401-***-****

** ************ ******, ***. # **, Boston, MA 02215

SUMMARY:

> Over 10+ years of experience as Programmer/Analyst in the building and

maintenance of Clinical Oracle Database with Clintrial and SAS (Base,

Proc SQL, Macro) RDMS tools using CDISC & SDASH International

standards.

> Clintrial Certified Clinical Study Designer.

> Advanced programming skills using SQL, PL/SQL and C++ languages.

> Strong experience in Data Management for Clinical Oracle Database.

> Sound knowledge of CRF/eCRF design.

> Extensive experience in writing custom PL/SQL codes for complex

validation procedures.

> Experience in Clinical Trials, Clinical Data Analysis, Study Build,

Validations, Documentation, Phase I to Phase III Clinical Drug Trials

studies using CDISC & SDASH International standards and other tools.

> Strong ability to understand and quickly apply new technologies and

information.

> Detail oriented, organized, enthusiastic to work in a fast paced and

team oriented environment.

> Excellent communication and interpersonal skills, capable of handling

multiple tasks and self-motivated.

> Worked on several studies which included moving SAS protocols into

Clitrial.

> Utilized in-house mapping tool to extract patient data into datasets

for statistical review.

> Possess the ability to rapidly grasp new technology.

> Good communicator who is equally comfortable working with technical

users and end-user clients.

SOFTWARE:

LANGUAGES: FORTRAN 4, PL/SQL, VB 2005, C++.

OPERATING SYSTEMS: MS Windows NT/XP/7.

DBMS: MS Office Suite, Oracle 10g, Clintrial 4.6, Oracle Clinical 4.6,

Adobe 6.0, SAS 9.

APPLICATIONS: Oracle Developer 3.0, Crystal Reports 12, Sourcesafe 2005,

Meditech 17.

Professional Training:

PHASE FORWARD Certificate, Clintrial 4.4 design.

Medical Coding Skills:

. EHR (Electronic Health Records) creation and management.

. CPT coding (Current Procedural Terminology) for clinical site data.

. ICD-9-CM (International Classification of Diseases 9th Revision,

Clinical Modification) coding.

. ICD-10-CM (International Classification of Diseases 10th Revision,

Clinical Modification) coding.

. Medical coding with MedDRA and WHO-DRL.

Professional Experience:

FEDERAL ELECTRONICS

04/2013-PRESENT

Cranston, RI

Electronic PC Boards/Scheme Designer (Laid off).

Responsibilities:

( Electronic PC Boards/Scheme design with AutoCAD 16.

( Electronic Cables/Harness design with AutoCAD 16.

( Blueprints inspection and upgrading.

MEDISOFTCONSULTING

04/2009-03/2013

Kiev, Ukraine

Clinical Programmer Analyst

Responsibilities:

Clinical study designs with Clintrial 4.6 and SAS 9 RDMS using CDISC &

SDASH International standards:

. CRFs design and annotation with Adobe 6.0.

. e-CRFs design with Clintrial 4.6: Items, Panels, Page sections, Page

templates, Blocks, Study books, Code lists.

. Edit checks/ data validation (Rules and Derivations) programming

against logic and standard data errors with PL/SQL.

. Data tracking set-up programming with PL/SQL.

. Data coding set-up programming with PL/SQL.

. Data entry processing set-up programming with PL/SQL.

. Data management and manipulation.

. Metadata creation, management and manipulation.

. Ed Hoc queries design for data retrieve.

. Programming, statistical analysis and reports production with SAS 9.

. Clinical Reports development in Excel format.

. Clinical studies conversion from SAS 8.2 to Clintrial 4.6.

. SOPs implementation in compliance with GCP and 21 CFR Part 11.

. Clinical Data Standards implementation in compliance with FDA.

Conditions: CDISC (Clinical Data Interchange Standard Consortium), CDASH

(Clinical Data Acquisition Standards Harmonization).

AVERION

09/2008-02/2009

Southborough, MA

Clinical Database Programmer Analyst (Contractor)

Responsibilities:

Clinical study designs with Clintrial 4.6 and SAS 8.2 RDMS using CDISC &

SDASH International standards:

. CRFs design and annotation with Adobe 6.0.

. e-CRFs design with Clintrial 4.6: Items, Panels, Page sections, Page

templates, Blocks, Study books, Code lists.

. Edit checks/ data validation (Rules and Derivations).

. Programming, statistical analysis and reports production with SAS 8.2.

. Clinical reports creation in Excel format.

Conditions: CDISC (Clinical Data Interchange Standard Consortium), CDASH

(Clinical Data Acquisition Standards Harmonization).

MEDISOFTCONSULTING 02/2005-

09/2008

Kiev, Ukraine

Clinical Programmer Analyst

Responsibilities:

Clinical study designs with Clintrial 4.6 and SAS 8.2 RDMS using CDISC &

SDASH International standards:

. CRFs design and annotation with Adobe 6.0.

. e-CRFs design with Clintrial 4.6: Items, Panels, Page sections, Page

templates, Blocks, Study books, Code lists.

. Edit checks/ data validation (Rules and Derivations)

. Maintenance and support of existing in-house applications (VB/ C

. Clinical reports creation in Excel format.

Conditions: CDISC (Clinical Data Interchange Standard Consortium), CDASH

(Clinical Data Acquisition Standards Harmonization).

HARVARD CLINICAL RESEARCH INSTITUTE 02/1998 - 02/2005

Boston, MA

Clinical Database Programmer Analyst

Responsibilities:

Clinical study designs with Clintrial 4.6 and SAS 8.2 RDMS using CDISC &

SDASH International standards:

. CRFs design and annotation with Adobe 6.0.

. e-CRFs design with Clintrial 4.4: Items, Panels, Page sections, Page

templates, Blocks, Study books, Code lists.

. Edit checks/ data validation (Rules and Derivations).

. Programming, statistical analysis and reports production with SAS 8.2.

. Clinical reports creation in Excel format.

Conditions: CDISC (Clinical Data Interchange Standard Consortium), CDASH

(Clinical Data Acquisition Standards Harmonization).

Education:

LINCOLN TECHNICAL INSTITUTE, Lincoln, RI

Seminar: Medical Terminology, Coding and Billing

CLARK UNIVERSITY, Braintree, MA

Certificate, Client/Server Application Development

KIEV UNIVERSITY OF MANAGEMENT, Kiev, Ukraine

Diploma, Management and Marketing

KIEV ENGINEERING INSTITUTE, Kiev, Ukraine

Diploma, Master of Science Degree in Mechanics and Mathematics

Languages: English, Russian, Ukrainian.

Status: Citizen of USA.

References: Available upon a request.

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