Covance

  • External Data Specialist 2

    Job Location(s) US-NC-Raleigh-Durham
    Job Number
    2018-23896
    Job Category
    Other
    Position Type
    Full-Time
  • Job Overview

    External Data Specialist

    Remote from anywhere in the U.S. or Canada

     

    JOB SUMMARY

    Be responsible for review, maintenance and update of safety laboratory/external data received from central or local laboratories. Working to ensure departmental SOPs, guidelines and global standards are followed to maintain coding integrity and ensure consistency across all projects as appropriate

     

    JOB RESPONSIBILITIES

    - Ensure electronic lab data contains all protocol specified lab parameters, is in correct format and data populates to the specified fields and patients correctly.

    - Review data discrepancies generated by study specific edit checks for laboratory data and assist in preparation of data clarification forms sent to the site or the central lab. Also, review missing/updated central laboratory data for potential request and substitution of local laboratory data.

    - Perform 100% validation review of the electronically transmitted data for 5% of total number of patients in the study for loading purposes.

    - Assist CDM Manager with review of laboratory edit checks, laboratory status reports and laboratory listings as necessary.

    - Interact with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning the normal ranges, and maintain proper documentation.

    - Enter and perform QC for local laboratory normal ranges. Verify the normal ranges are properly attached to the patient results in the local lab data collection module of the database. Responsible as contact person for the External source of electronic data transmissions. Keep the Central lab and client informed of problems involving data transfers, data point issues and validation issues.

    - CRF design, User Acceptance Testing (UAT) data review, and query writing experience preferred

     

    KEY SKILLS & BEHAVIORS

    - Produces high quality work using SOPs, guidelines and technical standards as defined by the global technical group

    - Keeps others informed of project and/or technical issues by pro-actively communicating across teams/functions

    - Manages time effectively in order to produce a quality deliverable in expected timeframe

    - Completes all tasks agreed upon with minimum supervision

    - Anticipates changing priorities and demands and addresses them proactively

                                                   

    TRAINING AND EXPERIENCE

    1. Medical Laboratory Technology (preferred), Medical or Life Science Bachelor Degree or relevant experience
    2. 1-3 years previous laboratory or clinical experience preferred

    Education/Qualifications

    TRAINING AND EXPERIENCE

    1. Medical Laboratory Technology (preferred), Medical or Life Science Bachelor Degree or relevant experience
    2. 1-3 years previous laboratory or clinical experience preferred

    Experience

    TRAINING AND EXPERIENCE

    1. Medical Laboratory Technology (preferred), Medical or Life Science Bachelor Degree or relevant experience
    2. 1-3 years previous laboratory or clinical experience preferred

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