Clinical Operations

  • location: Lexington, MA
  • type: Contract
  • salary: $18.79 - $22.10 per hour
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job description

Clinical Operations

Clinical Document Management Specialist I

Job Summary

The R&D Scientific Documentation group is offering a 6 month contract with the potential for extension to a detailed oriented graduate to assist the document digitization program, move to an inventory management program, and a physical space reorganization and optimization. Efforts will focus on the digitization of Shire's records from paper to PDF (including lab notebooks, and data binders), as well as working with off-site storage and scanning vendors, inventory management data entry, data normalization, as well as research to support divestments.

Job Responsibilities

  • Interacting with third party scanning vendor for off-site scanning:

    • Corroborate with Archivists in the preparation for shipment to third parties vendors and manage quality checks of materials scanned
    • Tracking and reporting of materials onsite and in scanning process
    • Maintain a triage "fix" log of vendor scanning errors
    • Ensure metadata is current and accurate
  • Supporting the logistics to centralize off site material to Shire preferred vendors
  • Assist with research requests for divestments and legal discovery
  • Optimize current physical space with reorganization of the collection
  • Support the integration of records acquired via mergers and acquisitions
  • Job Description:
  • Develop the Growing Archive Collection

    • Normalize metadata for entry into the Inventory Management system
    • Find gaps in recordkeeping metadata and reconcile issues autonomously
    • Work with RDSciDocs archive staff to design file structure in the archive, execute the operational activities to maintain a structure
  • Logistical Archive Activities

    • Manage off-site storage account for paper
    • Collaborate with Archivists to run scanning program
    • Logistics for the physical transfer of records to any purchasing company
    • Oversee the provenance chain custody and transfer of documents
    • Updating metadata: removing records from systems regardless of media type; updating metadata files;
  • Compliance

    • Ensure processes adhere GLP/GCP regulations and Shire policies
    • Establish standard process documents including, SOP, BBP, WI and Policies as needed
    • Maintain metrics for the physical portfolio of records and Programs to maintain physical records
Education & Qualifications

  • Bachelor's degree
  • Masters in Library Science or Data Archiving, preferred
  • Ability to manage competing and re-prioritizing tasks
  • Excellent verbal and written communication
  • Experience with SharePoint and Office 365 is preferred
  • Advanced experience with Microsoft Excel is preferred
  • Documentation, archive or laboratory science, preferred
  • Experience in conducting repetitive tasks, is a plus

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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