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Clinical Research Document Specialist I

Clinical Research Document Specialist I

Job Description

 

The Trial Document Specialist assists with the lifecycle management and associated processes (from study set up to archiving) of Trial Master Files (TMF) for clinical trials conducted within the Clinical Science and Innovation (CS&I) department, according to International Conference of Harmonization (ICH) and internal corporate guidance Trial Document Specialist Activities:

 

Core responsibilities applicable for studies following electronic trial master file (eTMF) procedure:

 

  • Supports Clinical Trial Leaders (CTLs) in the set up of an electronic Trial Master file process for assigned studies
  • Work with document systems and related group to ensure groups are trained on document management systems or other agreed process for electronic TMF document delivery
  • Work with sites to attain required regulatory documentation in a timely manner as required to meet timelines for study start up
  • Support CTLs in the maintenance of trial documentation.
  • Scan (or coordinate scanning by vendor), properly name, and import documents into the corporate document management system.
  • Act as subject matter expert and/or super user for document systems and other TMF technical tools.
  • Support set-up of electronic TMF Table of Content at study start and update as appropriate during study in agreement with CTL
  • Set-up of paper TMF folder structure & receipt of paper TMF documents from the Clinical Research Associate (CRA)/site at defined intervals during the trial for those originals still required to be on file, arrange for archiving of paper TMF at study end
  • As part of the global CS&I trial document group:
  • Participate in the creation/harmonization of templates/guidances, e.g. trial document delivery plan template, document tracking tools, training materials, TMF quality compliance (QC) guidances.
  • Assist in maintaining a global tracking of trial master file locations (during study and upon archiving)
  • As agreed, act as back-up or provide support to other Trial Document Specialists globally
  • Extended/ Optional responsibilities as agreed depending on local requirements and resource availability for selected studies


Job Requirements

 

  • An Associate's degree (for graduates) or equivalent qualification or work experience.
  • Relevant work experience is desirable
  • Good organizational and interpersonal skills.
  • Good knowledge of regulatory requirements and best practices pertaining to trial document management and archiving of clinical trial documentation
  • Good knowledge of Good Clinical Practice Ability to work independently and manage multiple priorities.
  • Computer literate.
  • Fluent in English
  • Some knowledge of clinical trial design, execution and operations would be beneficial.

 

NO sponsorship, NO relocation.  US based candidates only, please

Qualified candidates, please send current Word resume to: [Click Here to Email Your Resumé] for immediate consideration

 


Job Snapshot

Employment Type Contractor
Job Type Science, Pharmaceutical, Biotech
Education 2 Year Degree
Experience At least 2 year(s)
Manages Others Not Specified
Industry Biotechnology, Pharmaceutical
Required Travel Not Specified
Job ID 3999987
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Clinical Research Document Specialist I


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