OMNI Human Resource Management

  • Senior Data Manager

    Job ID
    2018-2287
    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 supporting clinical research? Vince and Associates Clinical Research is currently seeking a Senior Data Manager for their Overland Park, KS campus.

     

    The Senior Data Manager is responsible for the data management tasks for early stage clinical projects. They are accountable for the data management tasks of projects according to contracted services in compliance with current legislation, ICH GCP and appropriate company/sponsor procedures and quality standards. In addition, they are responsible for all phases of data management activities from study start up to database close.

     

    DP-IND

    Responsibilities

    • Performs data management processes; data entry, query resolution and closing queries, external vendor data reconciliation, listing review and creation of manual queries.
    • Go to expert for Data Entry personnel, Study Managers, Monitors.
    • Ensure all fields are captured and validation checks are complete.
    • Ensure tracking of all eCRF's and queries and identify incorrect status or missing information.
    • Identify errors and recommend corrective action as necessary.
    • Identify edit checks that fire incorrectly, identify missing data checks, range checks and skip logic not in place or that does not function applicably.
    • Support Lead Data Management role. 
    • Understand study specific database design in EDC system.
    • Understand the relationship between source and database forms related to data entry, queries, query resolution and external vendor data reconciliation.
    • Provide input into improving efficiency of data management tasks.  
    • Participate in continuous process improvement initiatives.
    • Provide EDC training (via WebEx) for CRAs and sponsor representatives. 
    • Other related tasks as assigned by the Lead Data Manager or managers of the department.

    Qualifications

    •  Bachelor’s degree in a scientific discipline or equivalent experience.
    • Minimum 2 years data management experience preferred or clinical and/or research experience with good understanding of clinical trials methodology and terminology.
    • Demonstrates success in technical proficiency.
    • Good knowledge of GCP and ICH Guidelines-including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
    • Awareness of CDASH and CDISC Standards.
    • Works on problems of complex scope where analysis of situations or data requires a review of a variety of factors.
    • Exercises judgment within defined procedures and practices to determine appropriate action.
    • Builds productive internal/external relationships.
    • Possesses an excellent knowledge in main areas relating to data management.
    • Ability to solve problems using logical and systematic approaches is critical.
    • Very good organizational skills, attentive to details with respect to SOPs.
    • Very good communication skills (both written and verbal in English)
    • Software: working knowledge of EDC systems.
    • Proficient in MS Office.

    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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