SUMMARY:

I have over Eight years of experience in 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., SAS, RAVE, Clintrial. Has excellent knowledge of statistical procedures, validation procedures. Knowledge of FDA Submissions and 21 CFR part 11.

TECHNICAL SKILLS:

Clinical Data Mgmt tools: Oracle Clinical 4.5., AERS, Thesaurus Management Systems (TMS), RDC (Remote Data Capture), (CRF, DVG, DCM, DCI, Global Library, SAS (BASE, SQL, STAT, MACRO, ACCESS, CONNECT, GRAPH, ODS), Macro EDC, eLoader
RDBMS: ORACLE, SQL Server, MS-ACCESS.
Report-Writing Tools : ireview, SQR, PSQuery, Crystal Reports.
Languages : JAVA, C++
Testing Tools: WIN RUNNER, LOAD RUNNER, TEST
DIRECTOR
Operating Systems : Unix, Windows NT/XP, Windows-95/98, MS DOS

PROFESSIONAL EXPERIENCE:

Confidential,
Waltham, MA March 2008 to Present
Responsibilities:

• 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
• 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 DCIs.
• 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 researchers needs.
• Initial pre-monitoring of CRF data through to writing SQL & SAS programs for reviewing database listings for cleaning of data to a very high standard.
• Perform an exact test to evaluate the success of the study using SAS/STAT.
• Generated graphs using SAS/GRAPH and SAS Graphics Editor.
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• 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 clinical systems were processed and batch loaded into Oracle Clinical.

Environment: Oracle Clinical (4.0.3, 4.5), SAS, MSSQL, Mysql, Teleform, Access, Solaris

Confidential,Nutley, NJ May 2006 to Feb 2008
Responsibilities:

• Providing study specific programming and planning support in technical areas as a member of the Data Management Services team assigned to a clinical project or study.
• Assisting with departmental co-ordination and resource management where necessary.
• Training and coaching of other location staff in Oracle Clinical, Macro EDC and related data management procedures.
• Coordinating all activities that apply to build Database in Oracle Clinical and Macro EDC, 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
• Responsible for Clinical database set-up, creating and maintaining clinical study databases, questions, DCMs, DCIs and DCIs-book, data entry screens layout and test within Oracle Clinical amd Macro EDC.
• 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.
• 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.
• Arranged local and central lab data into standard formats for Batch data Loading into Oracle Clinical 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
• Involved in upgrade of Oracle Clinical 4.0 to 4.5, Testing IQ/OQ/PQ scripts for new version.
• Developed SAS programs using Proc Tabulate, SAS Base and SAS/Stat that enabled users to generate reports on Daily/Weekly/Monthly/Quarterly/Annual reports.
• Generated Linear and Non-Linear Graphs using SAS/Graph.
• Performed SQL Queries to Retrieve, Modify and Updated data using SAS/Access.
• Worked with clinical research staff to develop or manage the annotated CRF and establish data validation rules.

Environment: Oracle Clinical 4.0, TMS, EDC, SAS, eLoader, SAS, PL/SQL, SQL, Mysql, Teleform, Access.

EDUCATION:

• MS in computer science