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Clinical Document Management Specialist I

Lexington, MARandstad LifeSciences

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Clinical Document Management Specialist I

True Title: Archive Technician 


Job Summary

(Six month contract position) individual to capture, and protect Shire’s Research and Nonclinical (GLP) documentation.  Must be able to handle sensitive and/or confidential documents and information with prudence. 

Job Responsibilities

Working member of an audit inspection-ready R&D paper and electronic Archives, responsibilities include following established procedures to: 

  • Process new materials added to the archive collection from onsite records created by laboratory scientists which includes but is not limited;
    • barcoding records with RFID tags 
    • data entry
    • generate reports and records manifests
    • apply legal hold metadata to boxes
  • Manage quality checks of scanned materials
  • Execute maintenance of offsite storage collection 
  • Support the integration of records acquired via mergers and acquisitions
  • Remediate of onsite storage, and reconcile with inventory management system

Education & Qualifications

  • Experience with  GXP records and laboratory notebooks preferably in a biotech, pharmaceutical, or healthcare environment, with 3 years  
  • GXP training is preferred 
  • BA or BS is preferred 
  • Must be able to lift 15-30lbs on a routine basis. 
  • Must also be able to use a stepladder to access physical records.
  • Experience working at an archive, or in a lab a plus
  • Experience with SharePoint, and inventory/content management systems such as OmniRIM, FileBridge,etc. preferred 
  • Familiar with document imaging hardware and software
  • Strict attention to detail 
  • Ability to operate independently and follow shire policies and departmental SOP
  • Focus on weekly production while handling ad-hoc requests
  • Operate as a member of a team in a regulated environment
  • Escalate quality and indexing issues of records to Archive Manager
  • Enforce Chain of Custody for all transactions
  • Improve Metadata and references to archived materials as needed
  • Hands-on experience with multiple IT solutions commonly used in the industry for data capture and utilization
  • Handle sensitive and/or confidential documents and information with  prudence
  • In-depth knowledge of Microsoft Office products suite
  • A collaborative and enterprising spirit
    Recent experience with SharePoint
  • Developing judgment, decision making and problem solving skills with the ability to assess issues and determine the best course of action.
  • Outstanding organization skills and communication
  • Consultative and collaborative style with an ability to work well with others


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance


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