OMNI Human Resource Management

  • Lead Data Manager

    Job ID
    2018-2135
    Client
    Vince & Associates Clinical Research
    Job Location(s)
    US | CA
  • Overview

    Altasciences- Vince and Asso

    Do you want a fast-paced, exciting and innovative career in research? Altasciences Clinical Research is currently looking for a Lead Data Manager to support the Vince & Associates Overland Park campus. This remote role may be flexibly located within the United States or Canada.

    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 Lead Data Manager is responsible for the data management for early stage clinical projects. Reporting to the Clinical Data Manager, they will be accountable for the data management tasks of projects according to contracted services in compliance with current legislation, ICH 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.

     

    Responsibilities

    • Develop, validate and maintain cinical databases, including data entry screen design and edit check programming
    • Interact with other various departments and clients (internal and external) to ensure that clinical databases and study documents data are complete, accurate and in compliance with regulatory requirements;
    • Execute data validation programs and generating queries
    • Perform data checks and test database prior to release into production
    • Provide input into improving and monitoring Data Management Standards and participation in continuous process/productivity improvement
    • Develop and maintain data management documentation
    • Develop data specifications, collecting, processing, and reporting for external data
    • Participate in continuous process improvement
    • Identify errors and recommend corrective action as necessary

    Qualifications

     

    • Minimum of 8 years 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
    • Good knowledge of GCP and ICH Guidelines including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing
    • Experience working with EDC systems, and/or database structures, including demonstrated skills in database design and programming
    • Work on problems of complex scope where analysis of situations or data requires a review of a variety of factors.
    • Exercise judgment within defined procedures and practices to determine appropriate action;
    • Excellent understanding of CDISC SDTM standards;
    • Excellent organizational and prioritizing skills;
    • Good communication skills (written and verbal in English is essential);
    • Highly autonomous and resourceful.

    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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