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    Clinical Data Associate Ii - Remote

    Thermo Fisher Scientific
    0-5 years
    Not Disclosed
    12 April 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description

     

    Summarized Purpose: 
    Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical devices. 

     

    Essential Function:

     Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required. 
     Generates, tracks and resolves data clarifications and queries. May implement 
    CRF design in identified graphic design package. 
     Reviews data listings for accuracy and consistency of data. Analyzes and 
    resolves data validation and other data management reports. 
     Produces project-specific status reports for CDM management and for clients on a regular basis. 
     Performs data management activities such as Serious Adverse Event and Third 
    Party Vendor reconciliations as well as Data Listing reviews. 

     

    Knowledge, Skills and Abilities: 
     Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations 
     Strong attention to detail and skill with numbers and ability to use interactive computer programs 
     Good written and verbal communication skills and a strong command of English language and grammar 
     Good organizational and analytical/problem-solving skills 
     Ability to work productively with moderate supervision 
     Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data 
     Strong customer focus and excellent interpersonal skills. 

     

     

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