SUMMARY:

• 8+ years of experience in development and support of CDR tool used for clinical data flow for drug discovery and trial level support for FDA or regulatory requirement.
• 10.5+ total years of IT experience as a software developer for clients in health care domain for SDTM (study data tabulation model), Merck MedDRA, drug and WHO drug encoding/ISOS leveling, MPR.
• 8+ years of experience in ETL (extract, transform and load) SDTM data as per business requirements and reporting.
• 1 year learning experience of cloud based AWS and Microsoft Azure and BISM Stack services like SSMS, SSDT, SSIS, SSAS and SSRS.
• Experience in SAS programming, macro for MPR report development and release on CDR database for regulatory reporting.
• Actively involved in the life cycle of the project, which includes Analysis, Design, Development and Implementation of the systems.
• Analyze, build and test new component or enhancement to existing module. Design and code applications to functional and technical programming standards.
• Worked on PSP functions and Clinical SDTM development and deployment of PL/SQL packages and procedures.
• Expertise in handling client’s queries via email, phone and conference calls for functional and technical support.
• Worked on remedy for incident management, change management and problem management.
• Ability to grasp new technologies and tools and quickly applies them in the projects.
• Extensively worked on Oracle 9i, 10g, 11g, PL/SQL Procedures, Functions, Triggers, UNIX shell scripts.
• Deployed and managed Solution Packages, Features and releases.
• Analysed, debug and provide work around for business critical need and FDA filing.
• Prepared requirement and design documents highlighting the project need.
• Leading multiple Development and Technical Production Support Projects with onsite and offshore team from requirements gathering through to implementation.
• Communicate weekly/daily status reports both on Development and Support, to the management and client.
• Conduct code review as per standards with the team on both development and support projects.
• Participate in Project initiation, Planning and Implementation meetings with the Client.
• Work as a technical lead SME for all technical issue for client application and tools.

TECHNICAL SKILLS:

Technologies and tools: Window 2003, 2007, 2010, UNIX, Microsoft outlook Exadata, Oracle 9i, 10g, 11g, PL/SQL, SQL performance tuning, Unix shell script, XML, SaS, Toad, SQL Navigator, Putty, J - Review, Excel Macro

Current Learning: Python, Hadoop, Big data, SQL Server, DB2, Postgres, Microsoft Azure including Active directory/Data Factory/Data Catalog, Analytics SQL databases/Warehouses/BISM Stack (SSMS, SSDT, SSIS, SSAS, SSRS)

PROFESSIONAL EXPERIENCE:

Confidential

Project Lead

Responsibilities:

• Support Central coding Applications hosted on windows 2003 server.
• Responsible for providing user access and trial set up and maintenance of central coding application.
• Responsible for maintenance of servers, installation of central coding server in case of upgrade.
• Responsible for requirement gathering, design, analysis, coding and testing module, Project Monitoring and Development of DMT analysis and reporting application.
• Lead the team of 4 offshore and 1 onshore developers.
• Documentation of requirement specification, design, code review, tests and deployment plan.
• Perform unit testing and help business in UAT testing.
• Requirement gathering, design, analysis, coding and testing module.
• Intelligently analyze dataflow and error logs to represent the dataflow status of a trial on dashboard.
• Documentation of requirement specification, design, code review, tests and deployment plan.
• Schedule Jobs to update the dashboard and issue fixing.

Tools: and Technology used: UNIX, Shell Scripting, Exadata, Oracle PL/SQL, SQL Navigator, XML, Java

Confidential

Responsibilities:

• Responsible for requirement gathering, analysis, design, coding and testing module.
• Documentation of requirement, design, code and SOP preparation.
• Small tool for business user to perform ISOS leveling in consolidated way.

Tools: and Technology used: Oracle PL/SQL, SQL Navigator, XML, Excel Macro, window 2007, SQL loader, Dos

Confidential

Responsibilities:

• Responsible for requirement gathering, design, analysis, coding and testing module for business deliverable. Project Monitoring and Development of MPR report application.
• Developed the business reporting tool called MPR (milestone preparation report) for business to monitor daily derivation issues in PDAM to CDR Dataflow space.
• Perform the integration, unit testing and coding the requirements.
• Lead the team of 4 offshore developers.
• Documentation of requirement specification, design, deployment plan and code review.
• Perform unit testing and help business in UA testing.

Tools: and Technology used: UNIX, Shell Scripting, Exadata, Oracle PL/SQL, SQL Navigator, SQL Developer, Toad, SAS, XML

Confidential

Responsibilities:

• Enhancement in Contivo tool for business to trigger the automatic dataflow from PDAM to CDR for CONTIVO application.
• Lead team of 3 offshore developers to build the application.
• Responsible for requirement gathering, design, coding, Project Monitoring and Development of the application.
• Build the application using Merck SDLC process ensuring timely completion of Design and Build, Test, Install and UAT phase.

Tools: and Technology used: UNIX, Shell Scripting, Oracle, PL/SQL, SQL Navigator, Toad

Confidential

Responsibilities:

• As an Onsite Lead for CDR Dataflow, responsible for leading the Technical development and support Team at offshore/Onshore to ensure data integrity is achieved prior to and at time of Database Lock (DBL).
• Responsible for CDR enhancement and bug fixing for new or existing requirements, its analysis, development, code and testing through ALM tool.
• SME for CDR derivation debug, ISOS leveling, CDR encoding, Merck MedDRA, drug and WHO drug dictionaries implementation.
• Collaborate with Data Management Team to identify processes requiring improvement, standardization or improved communication between teams.
• Lead the Tech Support Team to ensure proper communication is maintained between the Business and the Technical Support Leads. Communicate to Business any planned or unplanned dataflow disruption.
• Meet with both Business and Technical Leads on a weekly basis to identify any outstanding or reoccurring issues with CDR Dataflow and cross functional teams RaM Mapping, Contivo Support, PDAM EXH support.
• Collaborate with the Integration Maintenance and Operations Team to be aware of upcoming technologies that will have an impact on CDR Dataflow.
• Help data management team to close change request, eCRF updates, InForm query close at Confidential t level, database lock for FDA or regulatory reporting.

Tools: and Technology used: ALM, SQL Navigator 6.5, Exadata, Oracle PL/SQL, Unix Shell Scripting

Confidential

Responsibilities:

• Responsible for Migrating PDAM 4.5 to PDAM 4.6 Environment.
• Develop tool for business to validate PDAM 4.5 data vs PDAM 4.6 for data verification.
• Part of team of 5 offshore developers to deliver the project.

Tools: and Technology used: UNIX, Shell Scripting, Oracle, PL/SQL, SQL Navigator, SQL Developer, Toad

Confidential

Responsibilities:

• Responsible for receiving SDTM Mapping package and analysis of file format for deployment.
• Responsible for coding PSP functions as per requirement received from business.
• Debugging issues and applying fix for SDTM Mapping deployment package, sending redeployment for same.
• Resolve Incident/issues that come through remedy/e-mail.
• Provide solution to business for any type of business queries related to support work.

Tools: and Technology used: Oracle PL/SQL, Unix Shell Scripting