Clinical Document Manager (LS-220241)
Start Date: ASAP
Location: Greater Boston
Duration: 12 months +
Pay Rate: DOE
Type: Contract
Job Description The consultant will manage and mentor a team of 9 clinical document management specialist as they provide clinical documentation related support to programs/projects related to acquisitions of company products, eTMF on going development, inspection readiness programs, regulatory submissions support and other clinical documentation related projects. 

  • Knowledge and experience of clinical documentation regulations and guidelines
  • eTMF / TMF and experience managing and developing processes, protocols and SOPs for clinical documents and records.  
  • Practical project management experience 
  • Leading and/or mentoring small teams

Required Skills:
  • 10 or more years of related experience
  • Must have significant eTMF / TMF experience including the use of eTMF, knowledge of ICH/GCP guidelines relating to TMF and overseeing TMF related processes.
  • Working for biopharmaceutical companies or CRO’s supporting biotech 
    PMP certification preferred 

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