Quanticate UK - Head Office

  • Principal Clinical Data Management Programmer

    Job Locations IN-KA-Bangalore
    Posted Date 6 months ago(6/29/2018 9:58 AM)
    # of Openings
    Data Management
  • Overview

    • To administer, maintain and document the Oracle Clinical Instance
    • To manage the Oracle Clinical Global Library
    • To provide advice and training on the use of Oracle Clinical
    • To design, program and test study databases.
    • To provide technical support for systems deployed in CDM


    • Administer, Maintain and Document Oracle Clinical
    • To document all processes related to the administration, security, access and use of Oracle Clinical
    • To ensure all documented procedures are adhered too
    • Support the Oracle Clinical maintenance upgrades and update patches
    • Conduct and document systems validation in accordance to industry regulations
    • To manage the Oracle Clinical Global Library
    • Provide global library services to the Data Management department
    • Document, maintain and uphold data standards
    • Drive database development efficiency through the standardisation of GLIB objects, DCMs, DCIs and validation procedures
    • To provide advice and training on the use of Oracle Clinical
    • Provide structured training sessions to teach Oracle Clinical database development, validation procedure writing, testing, data entry and discrepancy management
    • Mentor CDM Programmers on database development best practices
    • Project management for allocated projects
    • To manage timelines and resource
    • To report progress against schedules to management
    • Set up of data management for allocated projects
    • To annotate the master CRF
    • To develop study databases and conduct formal testing
    • To program study database edit checks and conduct formal testing
    • To assist/prepare in the creation of all data management documentation as appropriate
    • Management of study files for allocated projects
    • To maintain study master file and to ensure that the correct documents are within the file when they become available for all allocated projects involving data management.
    • To produce a clear breakdown of bookable time for invoicing.
    • To be aware of and to work to the standards appropriate to the study.
    • To advise on possible improvements to procedures and standards.
    • To perform other reasonable tasks as requested by management.


    • Qualified to minimally BSc, BA or equivalent, preferably in a numerate discipline
    • Having relevant past experience within the pharmaceutical Industry.
    • A minimum of 5 years experience in a technical role within Clinical Data Management in the pharmaceutical industry.
    • PC Skills , including good knowledge of programmer software languages such as SAS / PL/Sql.
    • Knowledge of industry standard systems (Oracle Clinical, Clintrial etc )
    • Knowledge of EDC systems
    • Excellent people management skills
    • Good organisational skills
    • Good communication skills (oral and written), good analytical skills.


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