• EDC Programmer

    Posting Date 4 weeks ago(11/20/2018 12:39 PM)
    Requisition ID
    2018-5668
    Job Location(s)
    West Lafayette IN United States
    Travel
    Less than 10%
    Position Type
    Full Time
    Company
    Cook Research Inc.
    Category
    Clinical
  • Overview

    The EDC Programmer at Cook Research Incorporated is responsible for supporting multi-functional teams and the Data Management team through experience and expertise. The EDC Programmer will provide technical support as needed for IBM Clinical Development system functionality and will maintain program/project level perspective, focus and communicate effectively on technical and functional EDC programming and data management issues, activities, timelines and deliverables.

    Responsibilities

    • Database design specification in consultation with Data Management, Clinical Project Management, Statistical Programming, and Clinical Review

    • Collaborate on/update global library as appropriate according to best practices and new standards

    • Design/create and test clinical databases including forms, folders, data dictionaries, edit checks, derivations, custom functions, standard and custom reports (limited)

    • Validate specification to development through leading team review, co-programmer review, and User Acceptance Testing

    • Verify completeness of study deliverables prior to release

    • Maintains all required study documentation

    • Perform peer review for the studies built by other programmers

    • Responsible for the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules and Standard/Custom Reports

    • Serve as a resource for development and implementation of best practices in an effort to improve quality and streamline database build and data cleaning efforts

    • Provide EDC technical support to facilitate study timelines and deliverables

    • Manages timely-quality deliverables for the study teams for assigned protocol/study(s)

    • Conduct training on EDC database use to support internal users

    • Responsible to provide escalation of study specific functional issues, tool/vendor issues, testing and validation needs, enhancement requirements, custom functions and/or custom reporting

    • Provide expertise for problem-solving with clinical database technology, capabilities and functionality

    • Support development and review of SOPs, and Work Guidelines to promote consistency

    • Identify additional opportunities for standardization and departmental efficiency

    • Provide technical assistance and training to technical / non-technical personnel

    Qualifications

    • Bachelor's degree in Computer Science/Information Technology or Life Sciences preferred

    • Working knowledge of relational database design and FDA regulation 21 CFR Part 11

    • Excellent verbal and written communication skills, as well as interpersonal skills are required

    • Logical thinking, attention to detail and accuracy, excellent organizational skills, time-management skills, and problem-solving abilities

    • Ability to work effectively in both a team setting and independently with minimal oversight

    • Ability to prioritize workload and meet deadlines

    • Applied knowledge of EDC applications preferred

    • Clinical programming experience preferred

    • Proficiency in computer skills across multiple applications

    • Applied knowledge of CDISC/CDASH/SDTM preferred

    • Experience with clinical dictionaries; MedDRA and WHO dictionaries preferred

    • Qualified candidates must be legally authorized to be employed in the United States.  Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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