OMNI Human Resource Management

  • Database Builder

    Job ID
    2018-2134
    Client
    Vince & Associates Clinical Research
    Job Location(s)
    US-KS-Overland Park
  • Overview

    Altasciences- Vince and Asso

    Do you want a fast-paced, exciting and innovative career in research? Vince and Associates Clinical Research is currently looking for a Database Builder for their Overland Park, KS campus.

    Altasciences Clinical Research, encompassing Algorithme Pharma, Vince and Associates Clinical Research and Algorithme Pharma USA, is one of the largest early phase clinical research organizations (CROs) in North America. As a leading, full-service CRO, we have extensive expertise in the execution of a wide range of Phase I/II clinical studies, especially complex trials in healthy normal volunteers and patient populations.

    The Database Builder is responsible for building databases in the data electronic collection systems for the collection of study data from the clinic. The Database Builder is responsible for the setup of data cleaning tools within the system; i.e.  missing data checks, range checks, skip logic, programming edits, and design listings.

     

    DP-IND

    Responsibilities

    • Thoroughly read and understand each study protocol to ensure accuracy when building the databases for each study so that the correct data is able to be collected and analyzable when exported from the system
    • Work closely with support team to ensure issues within the database are identified and fixed correctly in a timely manner
    • Ensure all visits, forms and fields are captured and validation checks and listings are complete before testing of the database
    • Development and maintenance of database building documentation and the tracking of all Change Request forms
    • Suggest or challenge unnecessary data collection and identify gaps in content while correcting errors and giving recommendations for corrective action steps as necessary
    • Collaborate with Biostatisticians and SAS Programmers to identify and suggest standards of design types and to identify data that will require non-standard programming for the database design
    • Develop data specifications, collecting, processing, and reporting of external data
    • Provide input into improving and monitoring Data Management Standards and participate in continuous process and/or productivity improvement
    • Ensure associates are accountable for tasks in compliance with current legislation, ICH and appropriate company and/or sponsor procedures and quality standards

    Qualifications

     

    • Bachelor’s degree in a scientific discipline
    • Minimum of 8 years of data management experience; OR an equivalent combination of education and experience;
    • Experience in clinical research environment and/or good knowledge of clinical trials methodology and terminology
    • Proficient in MS Office
    • Excellent understanding of CDISC standards
    • Good knowledge of GCP and ICH Guidelines including international regulatory requirements for the conduct of clinical development programs- especially related to data handling and processing
    • Complex problem solving skills where communication (both written and verbal in English) are key to developing productive internal and external relationships
    • Excellent understanding of CDISC standards

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.

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