• Clinical Data Management Associate

    Job Locations US-PA-Exton
    Posted Date 1 month ago(5/23/2018 2:25 PM)
    Job ID
    2018-1085
    # of Openings
    1
    Category
    Development
  • Overview

    Idera is seeking a highly-motivated, analytical, detail oriented self-starter to be responsible for the review of data from the Electronic Data Capture system as well as external laboratory and imaging vendors.  Previous clinical development experience is not necessary, but is beneficial.

     
    The Clinical Data Management Associate will perform data review on clinical data and function as a liaison between vendors performing analysis of pharmacokinetic, pharmacodynamic, safety, and/or imaging data for Idera and the Idera study team.  The Clinical Data Management Associate will ensure that data transfer agreements are in place with external vendors and that the data specifications are consistent and appropriate for the planned analyses. 

    Responsibilities

    50%

    • Support the Clinical Data Management team and assist in performing data review on clinical data for accuracy and completeness.

    15%

    • Review data transfer specifications for Idera clinical trials and ensure that they meet the needs for data management, statistics, and clinical pharmacology.

    15%

    • Perform reconciliation on lab and imaging data.

    10%

    • Ensure Data Management documents and approvals are filed appropriately in the trial master file, reviewing for completeness and audit readiness.

    10%

    • Perform user acceptance testing of the study electronic data capture system.

    Qualifications

    Key Attributes

    • Strong team participation and leadership skills, including excellent interpersonal and communication skills.
    • Ability to seek guidance when required and inform manager of situations as they arise.
    • Capability and willingness to embrace new processes while learning new tasks.
    • Careful attention to detail and commitment to quality.
    • Acts with urgency, tenacity, resilience, flexibility and versatility.
    • Ability to cultivate and maintain relationships based on trust and respect.
    • Highly motivated and personally accountable.
    • Strong alignment with and demonstration of all Idera values.
    • Strong written and verbal communication skills.
    • Strong computer skills including knowledge of Excel, Word, PowerPoint, MS Project and Outlook.  

    Education & Experience Requirements

     

    Required

    • Bachelor’s degree, preferably in a science-related field
    • Expertise in working with MS Excel

    Preferred

    • Previous data management experience
    • Experience working with laboratory and/ or scientific data
    • Understanding of database structures
    • Programming skills (SAS, SQL, R, or other platform)
    • Experience with Medidata Rave

    Key Interactions

    • Idera data managers
    • Idera clinical trial manager
    • Idera biostatistician
    • Idera clinical pharmacology lead
    • Laboratory vendor project managers
    • Idera clinical scientist

    Other Job Requirements

    • Minimal travel required.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed