Document Specialist

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This is an exciting opportunity to work within a fast paced, busy environment for an innovative technology company. Headquartered in Blue Bell, PA, Wingspan Technology is a local software company serving global life science companies. This is a contract position with a competitive salary and flexible schedule. Training is provided, and there is opportunity for advancement.

Job Description

  • Process study documents in accordance with client and study requirements as per study-specific processes, Wingspan SOPs, and regulations, where applicable.
  • Liaise with study teams and other Document Management staff in order to fulfill job responsibilities and activities.
  • Maintain study files as per study and/or client requirements or in accordance with Wingspan and/or client SOPs/WPs and applicable regulations.
  • Complete activities related to document receipt and processing which may include but is not limited to: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.
  • Provide information necessary to complete client and/or departmental status reports as requested by Wingspan and/or client management
  • Inform manager of training issues, project activities, quality issues and timelines as directed.
  • Participate in training related to fulfillment of responsibilities as required by Wingspan and/or the client.
  • Liaise with Clients, as appropriate, on project issues when directed by Wingspan management.
  • Assist with study migrations which will include:
    • Creating document manifests and/or spreadsheets that will include document metadata for all documents included in the in-scope studies to be migrated
    • Maintaining the data in these manifests and/or spreadsheets as the studies continue to progress
    • Preparing the one or more Migration Manifest Files for each study migration
    • Interact with Client CROs and other interested parties as needed to communicate data issues.
    • Collaborating with Client business leads to ensure accuracy of data in the document manifests and/or spreadsheets
    • Work with Wingspan Migration Project Team to ensure quality data migrations
  • Handle special projects or duties as requested by Wingspan management.

Role Requirements

  • TMF (Trial Master File) and/or health sciences / drug development experience a plus
  • Knowledge of Clinical Studies documents preferred
  • Ability to successfully liaise with study project teams, staff, clients and management, as necessary.
  • Good oral and written communication skills and interpersonal skills.
  • Competent computer skills.
  • Good attention to detail
  • High school diploma is required.

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