Experience

• 

  Infosys

  Aug 2006 - Feb 2007

  Software engineer

  Design, development, testing, troubleshooting and debugging of the software.Ensure smooth implementation Have worked for small projects during training in various languages based on Banking Automation which required JAVA, J2EE1, J2EE2, Oracle, JSP, and also had worked for the project based on Unix Platform Analyzing of changes to be done in development environment, which caused error. Migrating of code in different environment.Troubleshooting of software for two clients.Shell scripting ,Creating JSPs for various Banking ApplicationsWriting PROCEDURES, PACKAGES, FUNCTIONS, TRIGGERS for the required logic in ORACLE and PL/SQL.Writing Unit and Integrated Test Plan for the respective projects.Worked for the C project on VC++6.0 platform on Telephone Directory System. Show less

• 

  Iqvia

  Apr 2007 - Sept 2009

  My Work Provides me Opportunity to deeply Interact with My Love:Oracle Database and SQL/PLSQL.Here in the Company, I work on Oracle Clinical 4.0.3 and 4.5, SAS, Crystal Reports, Inform Architect 4.5 Including Others.My work Involves Writing Procedures, Packages and Other Administration Tasks.I also Maintain a Training Database for Internal use.Trying my Hand in Linux and Python these Days. Installing, Creating, Maintaining and Trouble shooting Oracle Databases in Clinical Domain.Working as a Database Programmer,Therefore working on Clinical domain tools such as Oracle Clinical and SAS.Creating Clinical Databases and Maintaining themWriting Procedure, Function and other Procedural Units in Clinical domain

  • Clinical Database Programmer

    Apr 2008 - Sept 2009

  • Associate Clinical Database Programmer

    Apr 2007 - Apr 2008
• 

  Novo nordisk

  Aug 2008 - Oct 2008

  Consultant

  I am currently working as a consultant on behalf of Quintiles in Novo-Nordisk Head quarters, Copenhagen.My work involves basically EDC-OC Integration, Migration and process Improvement.I am also involved in IVRS data handling.

• 

  Inc research

  Sept 2009 - Apr 2011

  Clinical programmer

  Creating and Managing Clinical Databases using Oracle Clinical.Writing edits, importing , exporting and other various functions in OC.Main Technical Activities:(1) Creation of Annotated CRF(2) Study Creation in Oracle Clinical(3) Database Design for a study(4) Procedure Creation(5) CRF and External Data import into Oracle Clinical(6) Import of External Data into tables outside Oracle Clinical using SAS(7) Export and listings Programming using SAS(8) DB lock activities. Show less

• 

  Novartis

  Apr 2011 - now

  • Select, recruit, develop, manage, motivate, coach and assess performance of direct reports including high quality performance management across the group• Lead & Drive various Functional, Operational and other Projects and Initiatives across Data Operations, GDO and wider organization.• Coordinate the development and maintenance of all CDDRA CoE deliverable on all systems and ensure that these deliverable are on time and of high quality.• Propose creation of new SOPs and working practices where appropriate,• Provide input to and undertake the implementation and maintenance of such documents and standards.• Interface with internal and external business partners (e.g. DO Standards and Process Development) in order to improve processes and systems.• Establish and maintain sound working relationships with partners and customers.• Represent department at any meetings and provide timely feedback to partners and Clinical Reporting and Analytics teammates.• Support the Global CDDRA Head with defining and revising processes that help to gain speed, increase efficiency and raise the quality of deliverables.• Lead, support or provide mentoring to staff members involved with special projects both clinical and non-clinical in nature. • Understands Health Authority requirements and is able to participate in Health Authority inspections as required with support from the other team members.• Establish training programs (technical and professional skills) for staff and ensure staff training is conducted and properly documented.• Global coordination of cross functional projects or TA specific aspects.• Represent line function at the appropriate governance standard board meetings • Assist Global CDDRA Head in the management of travel budget, global resources forecasting• May act as site head and/or deputy for Global CDDRA Head. Show less • Responsible for technical strategies and support for the programmers and analysts within the data review reporting & analytics group.• Technical business ownership of data review tools created by data review reporting & analytics team and ensure all environments and tools are enhanced in a timely manner, within allocated headcount of high quality. • Perform technical investigations and drive technical resolution for any identified issues and continue to support the strategy and vision for the group.• Ensure all tools continue to work as appropriate with changes in data governance and metadata. In addition represent the group and technical / business knowledge of data within the end to end data governance.• Drive technical training, mentoring and educations around the contents and use of tools.• Work closely with the programming team to ensure all required tools are developed and deployed in a consistent and timely manner.• Manage any system upgrades with appropriate communication to stakeholders.• Be the technical SME for clinical data review and reporting. • Partner with the team and other line functions to assess data review and reporting needs and create fit for purpose solutions. • Responsible for providing input or authoring global SOPs and business guidance's directly impacting the function and for reviewing and providing input to SOPs and BGs when applicable. • Instruct and manage work performed by external partners including input and review into documents. • Create, file and maintain appropriate documentation for tools and systems in accordance with Clinical Quality Assurance guidelines and conforming to Computer System Validation (CSV) requirements.• Represent line function at the appropriate governance standard board meetings • Act as a trainer, mentor, or coach to new or less experienced associates on end to end processes.• Deputize as necessary for supervisor. Show less Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specification and with programmers to implement the optimal output. Translate business requirements into logical models and provide direction to the development team to translate business logic.Proactively identify or address needs for optimal data review working with users and programmers as appropriate.Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner.Provide co-ordination between the project resources so that deadlines are met on deliverables.Drive development of appropriate user training. Drive all necessary change management activities related to implemenation of new data review tools / reports as related data cleaning, review and visualization.Provide understandable and actionable reports for key stakeholdersProvide quantitative analytical support to the global program teams, including providing support on analyzing reportsSystematically sample / monitor utilization of reports and tools, perform and coordinate periodic review of outputs. Report findings and take necessary steps to ensure reports are being for optimal data review.Work with the internal SMEs and key stakeholders in providing analysis and interpretation business and operational dataLead initiatives within Analytics, including training, to support overall compliance and adherence to data review through robust reports and tools. Proactively identify and address areas of concerns to avoid issues and ensure consistency, accuracy and completeness of reported data. Show less * Leading and contributing to Major projects and initiatives.* Mentoring, Training associates* Independently provide timely and professional ongoing management of projects and clinical trials by developing and maintaining trial specific database applications, including eCRFs and database specifications, program validation and derivation procedures of various level of complexity within the clinical database management system in support of in-house and outsourced trials globally for Phase I-IV * Support or lead a special project (strategic, larger in scale and scope) both clinical and non-clinical in nature. * Translate disease area knowledge into technical solutions in order to meet the needs of the franchise/business unit. Manage relationships and measure performance of external partners.* May assist manager in coordinating and directing DB Programming activities of project teams to enable them to be conducted to a consistently high standard with respect to quality and timelines. Show less * Contribute to the review of global SOPs and business guidances directly impacting the function and providing input when applicable* Develop the eCRF layout and corresponding database according to documented trial specific requirements, using components from existing libraries* Create, test and maintain trial specific plausibility and consistency checks* Provide data transfer specifications for third party data* Maintain and update the eCRF application and its components as required for protocol amendments or required post production changes* Develop database specifications, provide guidelines for db setup, review externally created documents, and interact with external partners for outsourced trials* Create, file, and maintain appropriate trial documentation* Program and test complex procedures, according to documented trial specific requirements, within the clinical database management system using SQL or PL/SQL* Maintain and update procedures as required for protocol amendments or required post production changes and ensure project level consistency* Creation & execution of trial design reports based on trial and project metadata* Demonstrated experience in the concepts and use of Clinical Data Standards (e.g. SDTM, Novartis standard) preferrred. Understanding of Data Models and implementation for database development* Supervise the work of less experienced associates.* Act as a trainer to new or less experienced associates on specific task(s)* Lead in the development and maintenance of project specific libraries for small projects within in their function* Subject Matter Expert in functional and technical process and systems* Serve as Project DB Developer for smaller projects Show less Develop and maintain trial specific database applications, including eCRFs and database specifications, program validation and derivation procedures within the clinical database management system in support of in-house and outsourced trials globally, of various levels of complexity for Phase I-IV independently or with minimal supervision. Support a special project of limited scope (sub team lead, local project, etc.) both clinical and non-clinical in nature. Provide study level expertise and involvement in CTTs.Develop the eCRF layout and corresponding database according to documented trial specific requirements using components from existing libraries.Create, test and maintain trial specific plausibility and consistency checks.Provide data transfer specifications for third party data.Maintain and update the eCRF application and its components as required for protocol amendments or required post production changes.Develop database specifications and provide support for outsourced trials.Create, file and maintain appropriate trial documentation.Program and test procedures of various levels of complexity from documented trial specific requirements, within the clinical database system using SQL or PL/SQL.Maintain and update procedures as required for protocol amendments or required post production changes.Creation and Execution of trial design reports based on trial metadata.Good knowledge of Clinical Data Standards. Understanding of Data Models and implementation for database development.Act as a trainer/mentor to new or less experienced associates on specific task(s).Contribute in the development and maintenance of project specific libraries. Show less * Develop the eCRF layout and corresponding database according to documented trial specific requirements using components from existing libraries* Create, test and maintain trial specific plausibility and consistency checks* Provide data transfer specifications for third party data* Maintain and update the eCRF application and its components as required for protocol amendments or required post production changes* Develop database specifications and provide support for outsourced trials* Create, file and maintain appropriate trial documentation* Program and test complex procedures, from documented trial specific requirements, within the clinical database management system using SQL or PL/SQL* Maintain and update procedures as required for protocol amendments or required post production changes* Creation & execution of trial design reports based on trial metadata* Understanding of Novartis Clinical Data Standards for procedures development Show less 1. Develop the eCRF layout and the database corresponding to the eCRFs to hold the data from the OC-RDC system.2. Create, test and maintain trial specific plausibility and consistency checks.3. Create the data extract specifications.4. Provide the data transfer specifications, test transfers and load third party data.5. Maintain and update the eCRF application and its components as required for protocol amendments or required metadata updates.6. Support CRO trial activities, including CRF annotation, database setup, specification generation and dataset comparison.7. Create and file trial documentation.8. Participate and/or lead in non-clinical task forces and initiatives to enhance productivity and quality.9. Perform second review of peer deliverable.10. Mentor new hires in CRO and/or EDC activities, as assigned.11. Prepare to offer advice on specific topics as a subject matter expert. Show less

  • Group Head, Clinical Data Acquisition & Management - Center of Excellence

    Jan 2020 - now

  • Functional Head (Associate Director), Data Review Reporting & Analytics

    Jan 2018 - Dec 2019

  • Principal Business Analyst

    Sept 2016 - Dec 2017

  • Expert Database Developer

    Sept 2015 - Aug 2016

  • Senior Database Developer

    Apr 2015 - Sept 2015

  • Senior Database Developer I

    Oct 2013 - Apr 2015

  • Database Developer

    Apr 2012 - Sept 2013

  • eCRF Developer II

    Apr 2011 - Mar 2012