Data Oracle

Pradeep Kumar Singh

** ****** ******, # **, **********, NJ 07095

SUMMARY:

* ***** ** ********** ** IT industry which includes experience in implementation and Development of

Software applications related to clinical data management. Have extensive experience in Clinical trials data

management using Oracle Clinical 4.0.3 & 4.5. Data Plan, Data Design, GLIB, Data Definition, validation

procedures.

TECHNICAL SKILLS:

Clinical Data Mgmt tools Oracle Clinical 4.5.(CRF, DVG, DCM, DCI, Patient Positions, Treatments &

Randomization, Global Library, Data Extract, Character/Graphic Layout Editor,

procedures, Data Entry, Mass Update, Batch Data Load), SAS, MEDIDATA.

RDBMS: ORACLE, SQL Server, MS-ACCESS, Excel VBA, & MS Excel.

Report-Writing Tools : SQR, PSQuery, Crystal Reports, Cognos.

Languages : JAVA, C++

Development Tools : JDK 1.2, JDBC, JSDK, RMI.

Testing Tools: WIN RUNNER, LOAD RUNNER, TEST DIRECTOR,

DataWarehousing Tools: Informatica, Cognos

Web Technologies : JAVA APPLETS, SERVLETS, JDBC, JavaScript, XML, HTML

Operating Systems : Unix, Windows NT/XP, Windows-95/98, MS DOS

PROFESSIONAL EXPERIENCE:

Bausch & Lomb, NY March 2008 to Present

Oracle Clinical Programmer

Responsibilities:

Involved in data management role for ongoing clinical trials.

Setup study database in accordance with global standard in support clinical trial using Oracle Clinical

Program and test Study Specific data Validation and Derivation checks

Used eLoader for assigning and updating Patients, Sites, and Investigators

Used eLoader for Standard validation checks.

Used eLoader for The validation check for checking DVG values now also checks data in Thesaurus

DVGs

Used eLoader for Custom validation checks can be added to the system

Provide Study Specific Support to the Data Management Team

Develop and maintain program in a validated environment

Design, create and validate studies in Oracle Clinical.

Extensive experience in maintaining the Global Library, creating questions, question groups, DCM and

DCI’s.

Developed validation and derivation procedures to meet the study needs.

Extensive CRF design experience, firm understanding of user interface design principles.

Have a firm understanding of HIPAA and CFR Part 11 standards.

Created custom reports using PL/SQL were developed for researchers.

Datasets of the clinical data from Oracle Clinical were generated to meet the researcher’s needs.

Worked with other team members in creating analysis datasets, discrepancy analysis and in reviewing the

case report forms as needed.

Batch-loaded electronic data from various databases such as MSSQL, Mysql and Access. Data was

formatted properly and loaded into Oracle Clinical. Laboratory data was also batch loaded into Oracle

Clinical.

Data from various medical equipment was processed and batch loaded into Oracle Clinical.

Worked on Teleform (OCR application) and loaded data gathered using this application into Oracle

Clinical.

Responsible for the proper coding, documentation and validation of SAS Pro grams/macros/procedures to

produce the standardized data display.

Monitor monthly SAS production processes; modify programs when needed per user requests and per

production environment.

Programming in SAS to retrieve data using SQL from various claim databases, join/merge different claim

data to create data for statistical analysis/reports sent across to various vendors/clients.

Provided training and mentoring to client staff on Oracle clinical.

Customization including use of MS-ACCESS, Excel VBA, & MS Excel.

Environment: Oracle Clinical (4.0.3, 4.5), Windows 2003, MSSQL, Mysql, Teleform, MS-ACCESS, Excel

VBA, & MS Excel, Solaris

Fujisawa, NJ May 2006 to Feb 2008

The Global Pharmaceutical Research Development division of Fujisawa has two sections mainly drug

discovery group and drug development group. Drug development group conducts clinical trials. I was

Involved in the studies of Phase I and Phase II clinical trials of prostrate cancer in men.

Responsibilities:

Coordinating all activities that apply to build Database in Oracle Clinical, which adhere to standard and

facilitate Data collection, Data cleaning and Statistical analysis.

Good knowledge of Front end and Back end of Oracle clinical Application with a proactive approach to

get the complete study done.

Good exposure to develop & design annotated CRF (aCRF) using Acrobat Frame maker 7.0

Worked with CDPs & CDCs to design Edit Check - Data Validation Plans for Clinical Studies

Experience with Oracle Clinical TMS for Oracle Clinical data collection setup and Question sets

creations.

Created and Tested Validation and Derivation procedures using Oracle Clinical application and using

custom code with PL/SQL and SQL, in order to maintain data accuracy and track the results of the dru g

trail in accordance with SOP, DMP and 21CFR Part 11.

Involved in creating & testing application according to the study design document & CRF

Testing Data entry screens, Validation procedures, derivation procedures and extract views, which will,

needed for manual reviews & statistical reviews.

Created and extracted Data Extract views, view templates in Oracle Clinical.

Managed pharmaceutical data and evaluated Clinical Data Coordinator request to gather additional

information and generating various reports relating to clinical studies.

Arranged local and central lab data into standard formats for Batch data Loading into Oracle Clinic al and

used eLoader 3.1 to map external data to load into Oracle Clinical 4.0

Generated various Clinical Trials reports using Integrated Review 6.0.5 for SRS (Standard Reporting

System) analysis

Participated in effort to standardize and enhance the re-use-ability of clinical library objects.

Involved in upgradation of Oracle Clinical 4.0 to 4.5, Testing IQ/OQ/PQ scripts for new version.

Worked with clinical research staff to develop or manage the annotated CRF and establish data validation

rules.

Environment: Oracle Clinical 4.0, Medidata, PL/SQL, SQL, Mysql, Teleform, Access,.

Tech Mahindra India Limited, India Feb 2004 to May 2006

Programmer

The Payroll Management System maintains detailed records on all employees and permits authorized

personnel to obtain a variety of reports on an individual employee or a selected group of employees. When an

employee leaves the Organization, his record is only flagged or marked as inactive but not deleted from the

file. Deleting inactive records is done later as part of year end maintenance.

Generated customized interactive screens and summary reports for transactions such as calculation of

monthly salary of employees, provident fund, professional tax, loss of pay, salary advances, attendance

and monthly conveyances.

Assisted in designing and creating the tables, forms and reports.

Advanced studies in translational research on aging.

Environment: SQL, Oracle 7.x with Developer 2000, Windows’95

Tata Motors Mumbai, India Sep’2001 to Feb 2004

Programmer

Responsibilities:

Developed Master Forms using SQL Forms 3.0.

Developed a number of reports using ORACLE tools, viz., SQL*Report Writer, SQL*Report.

Used SQL*Plus to create schema objects tables and indexes.

Involved in preparing User Documentation.

Environment : SQL, PLSQL,Oracle 7.x with Developer 2000, Windows’95

EDUCATION:

Bachelor of Computer Engg, Mumbai University, India, 2001

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