Sql Data
Resume:
DURGA PRASAD GUBBALA
Email: ************@*****.***
Phone: 862-***-****
___________________________________________________________________________________
Summary:
Working as a Sr. Clinical Analyst /Lead, by providing Clinical trial database support and Enterprise
share architecture using SQL, PL/SQL, Toad/SQL Navigator, CTS (Clinical Trial Systems) and oracle
9i and 10g applications, prior to this worked in Novartis Pharmaceuticals as Sr. Clinical Informatics
Analyst using PhaseForward ClinTrial modules and also worked in Australia, New Zealand and India
with various applications as an analyst programmer. Did my Post graduation in computer application
from India and computer diploma from New Zealand.
Experience Summary:
• Over 8 years experience in Pharmaceutical Industry Developing and supporting clinical
systems with worldwide usage and 3 years in IT systems/applications, primarily in the area of
client server and web environment.
• Work experience in pharmaceutical industries using oracle 8.0.6, 9i, 10g, SQL, PL/SQL,
SQL*Loader, CTS support, Clintrial 4.2/4.3, ClinAdmin, I-Review, Inform and Impact databases
• Worked in large team environments with various user groups, with involvement in business
analysis, application design, and development and testing process.
• Extensive knowledge in all the modules using CT4/Clintrial applications.
• Knowledge in developing applications using power builder, visual basics and developer 2000.
• Exposed to entire life cycle of project that includes data modelling, design, coding, testing,
clinical study development, and data collection workflow processes, implementation and use of
oracle designer case tools and oracle developer.
• A strong customer focus. Ideally, a basic understanding of IT Service management (ITIL) and
Computer System Validation (21 CFR Part 11, GxP guidelines.).
• Worked on Pharmaceutical Validated Systems. Pharmaceutical experience, particularly in
GxP and Validation concepts and processes
• Follow ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies
• Knowledge of the whole system of development life cycle (SDLC)
• Ability to multitask and work productively with minimal supervision
• Extensive experience in writing PL/SQL programming units like triggers, procedures,
functions and packages in Unix and windows environment.
• Knowledge of object oriented design and web applications.
• Excellent verbal and written communication and organizational skills
• Experienced in writing test cases, test scripts, reporting and documenting the test results
Education:
Diploma in Computer Science, Central Institute of Technology, New Zealand
Post Graduate Diploma in Computer Applications from Softcom Systems, India.
Master of Commerce Osmania University, India
Certifications:
Brain Bench certified for Oracle PL/SQL
Professional Qualifications:
Certificate course in ITIL Foundation course
Certificate course in Java – Victoria University, New Zealand
Certificate course in Oracle – Softcom Systems, India
Technical Skills:
Operating Systems UNIX, Win 3.1, 95, 2000, MS Office, Win NT & MSDOS
Languages C, COBOL, PL / SQL, SQL * Loader, Java, HTML & DHTML
RDBMS Oracle 10g, Oracle 9i, Oracle 8, Oracle7.x, MS Access
GUI Tools Clintrial 4.2/4.3, Developer 2000 & Power Builder 6
Third Party Tools CTS, I-Review 5.0, SAS, Review Admin 5.0, SQL Navigator, Toad,
Documentum, Table Trans, CT Navigator 4.1 & 4.2, ClinAdmin,
Impact, Inform, ClinTrial, Oracle Clinical and ClinTransfer
Professional Experience:
Apr 2007 to till date
Merck Pharmaceuticals
Sr. Informatics Analyst / Lead
Responsibilities:
• Provide professional, courteous and timely user support to global users with Clinical Trial
System (CTS) applications
• Act as a trouble shooter by identifying problems
• Resolve day-to-day issues/concerns related to ESA and various customisations
• Support and training for users
• Troubleshoot evoc web services
• Full understand in Metadata tables in CTS
• Respond back to data check requests from Vocabulary Managers.
• Understand MedDRA reports and the need to do MedDRA reporting.
• Assist in Monthly reports for WCDMO and level 3 change
• Overall knowledge in Drug Research and Development Program/Process.
• Involved in Oracle 10g upgrade and validation project
• Issues resolved in timely manner to full fill the SLA
• Use Oracle, SQL, PL/SQL, MS SQL Server and SQL loader on day to day process
• Worked as a team lead on multiple projects from initiation to completion - including
completion of deliverables in a timely and cost-effective way
• Handle projects from start to finish and manage in house and off shore people
• Review and approve Test Plans and check off documents
• Design database objects including Tables, Views, Triggers, Procedures and, Packages etc.
• Participate in regular team meetings to track progress and resolve issues
• Maintain regular communication with customers, gathering feedback on planned and potential
service improvements
• Act as 1st 2nd and 3rd level support to identify the issues and assign to next level support or call
vendor to report the issue.
• Provide ad-hoc queries, and reports from the shared data repositories and run monthly
scheduled reports using Cognos reports.
• Implement and maintain databases that are required to collect clinical data.
• Familiarity with medical terms associated with the Electronic Data Capture (EDC), Visual
Basic, basic SAS, MedDRA, WhoDrug and Pharmaceutical studies
• Transferring data between development and production system by means of exports and
imports
• Coordinate communications to the business users of the shared data
• Versioning of the MedDRA dictionary, follow computer System Validation (21 CFR Part 11,
GxP, ICH/GCP guidelines and clinical trial methodologies
• Participate in business analysis for new system functionality
• Support Inform, CPAC and CTMS users.
• Preparing test plans and OQ/PQ testing
• Working both independently and as part of a team
• Contribute to the design and implementation of new capabilities including those to enhance
the value of the information service and achieve operational efficiencies
• Developing and/or performing User Acceptance Testing (UAT
• Knowledge of object oriented languages like java and c++
• Key contributor to operational excellence at both support and system levels.
• Excellent overview in MS office applications, Window OS and NT file systems
• Follow the ITIL process for release plan.
• Writing technical manual for the program units and user change guide and store into
Documentum database
• Write Unix shell scripts to load the data and move data from one server to other server
Environment: Oracle 8, 9i, 10g, Toad, SQL, PL/SQL, MS SQL Server, CTS, Inform, ESA,
Informatica, Windows NT, HTML, XML, .NET, Java, Cognos Reports and UNIX
Feb 2001–Mar 2007
Novartis Pharmaceuticals
Sr. Lead Clinical Informatics Analyst/DBA
Responsibilities:
• Supports business in diagnosing, fixing and enhancing the ClinTrial 4 system.
• Works with Novartis internal support personnel (Level 1, 2 and 3). Provides training and
guidance on solving and implementing solutions to problem and enhancements.
• Acts as an expert technical resource that can provide comprehensive technical consultation to
business unit and IT management and staffs at the highest technical level.
• Performs related duties as assigned or requested.
• Assist Level 1,2 and 3 associates in diagnosing operational problems
• Lead in formulating the solution for the problem, and in design/implementation/roll-out
• Provides technical expertise in improvements in technical/process areas to reduce operational
issues
• Lead in creating technical documentation addressing gaps in current documentation
enhancements
• Lead in architect, design, implement and rollout of enhancements
• Works closely with the business organization to formulate technical solutions
• Ensure the development team adheres to the software development process
• Train and Mentor team members in ClinTrial system to improve their technical abilities on
problem diagnostics, resolution and implementation.
• In-depth working knowledge of ClinTrial 4 in architecture, design and operations.
• In depth knowledge in Clintrial metadata
• Creating data entry screens, write edit check programs and maintain metadata
• In-depth knowledge of Oracle, particularly PL/SQL and Oracle Materialized views
• Experience as an architect, also lead in design and operational support (problem diagnostics
and resolution) in a multiple-site deployment scenario
• Experience in working closely with the business - can clearly translate business
problem/requests into technical requirements
• Good understand in Valero knowledge
• Demonstrate effective use of tools in diagnostics/design
• Provide professional, courteous and timely user support to global users with Clintrial
applications
• Act as a trouble-shooter by identifying problems and support data manager.
• Resolve day-to-day issues/concerns regarding Clintrial 4 and various customisations
• Involved in CT4 upgrade and validation project
• Create Data pool Protocols according to requirements
• Create user accounts and manage security for all Clintrial Modules
• Create Clintrial Protocols panels, items, code lists, write validation checks and database set-up
• Maintain CTSDD, CTSCODES accounts follow computer System Validation (21 CFR Part
11, GxP, ICH/GCP guidelines and clinical trial methodologies
• Create code list according to Standard Abbreviation Dictionary (SAD)
• Uses Integrated Review (I-Review) tool to create and execute reports
• Loads Lab data by using Clintrial Lab loader
• Manages, validates clinical data by using Clintrial Mange
• Distribute Protocols and all objects, code lists by using Multisite
• Extract SAS data sets from I-review and transfer the data sets into GPS directory.
• Perform DB locks, user access rights, crate new user accounts, and grant required access and
Database support.
• Create Metadata Set-up & Local Coding views for Protocol having DATAPOOL for protocol
• Experience in dealing with external sources of data (i.e., Convince, Clinpharm and central
labs)
• Use Oracle, SQL, PL/SQL and SQL loader on day-to-day process
• Installation of Clintrial, support, testing, backup/recovery and management of Oracle
databases
• Grant Permissions for creating local views
• Validation of Local Coding views for protocol
• Develop e-crf forms using PhOSCo (Novartis in-house EDC product similar to Inform).
• Implement and maintain databases that are required to collect clinical data.
• Familiarity with medical terms associated with the Electronic Data Capture (EDC), Visual
Basic, basic SAS, MedDRA, and WhoDrug and Pharmaceutical studies
• Run SAS data extracts using I-Review
• Transferring data between development and production system by means of exports and
imports
• Preparing test plans and OQ/PQ testing
• Knowledge of object oriented languages like java and c++
• Key contributor to operational excellence at both support and system levels.
• Excellent overview in MS office applications, Window OS and NT file systems
• Follow the ITIL process for release plan.
• Writing technical manual for the program units and user change guide and store into
Documentum database
• Write Unix shell scripts to load the data and move data from one server to other server
Environment: Oracle 8, 9.i, Toad, SQL, PL/SQL, PhaseForward Clintrial, Citrix I-Review SAS,
HTML, XML, Windows NT and UNIX
Feb 1999–Dec 2000
Figtree Systems, Sydney
Programmer Analyst
Responsibilities:
• Design the complete database objects including Tables, Views, Packages, and Procedures etc.
• Active involvement in designing the Forms for the system using Developer2000
• Involved in framework design and coding transactions and reports.
• Wrote stored procedures using PL/SQL optimum retrieval of data for various reports.
• Test data preparation, unit and system testing
• Prepare user documents
Environment: Oracle 8, SQL*Navigator, SQL, PL/SQL, Oracle Forms 4.5, Reports 2.5 and Windows
Jan 1997– Jan 1999
Prudential Insurance, NZ
Programmer
This application was designed to handle every aspect of orders from customers - including customer
information, tracking orders, shipment status, warehouse item information, feeding data invoice-billing
system.
Responsibilities:
• Identify, analyse and document business processes.
• Responsible for designing & coding of the framework using Forms and Reports
• Design the Application architecture, identify, design and distribute the jobs between Client
and Server.
• Develop the development Project Plan, identify and assign various tasks within the team, users
and management.
• Develop and coordinate the testing, deployment and maintenance of various application
versions.
• Written triggers for GUI interface forms and reports.
Environment: Oracle 7.3, SQL*Navigator, SQL, PL/SQL, Oracle Forms 4.5, Reports 2.5 and
Windows
Mar 1993– Apr 1995
Galaxy Phrama, India
Analyst Programmer
Responsibilities:
• Database design, preparation of programs specification.
• Design and development of forms and reports.
• Test data preparation, unit and system testing
• Capturing the user requirement for the MIS system
• Data modelling in terms of logical and physical database design
• Design and coding of common objects required bringing about a common functionality
• Written PL/SQL procedures, functions, packages to troubleshoot problems, generating reports
and ad hoc queries.
• Assisting system engineer/administrator personnel to analyse/solve the problems, reporting
bugs in the system to development team and modify the code and applying the patches.
• Also involved in the design and develop of various web pages to populate this data into the
database using the ODBC connectivity.
• Testing in various phases and debugging the code using testing tools.
Environment: Oracle 7.1, SQL*Navigator, SQL, PL/SQL, Oracle Forms 4.5, Reports 2.5, Visual
Basics and Windows
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