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Clinical Document Specialist /QC Specialist

New Jersey All, NJ

Post Date: 08/12/2018 Job ID: JN -082018-22282 Job Type: Clinical
  • Support Clinical Pharmacology trial managers, pharmacologists, and pharmacokineticists by performing the Quality Control (QC) review (of content), formatting, and publishing/maintenance of key documents (for example, protocols, clinical study reports, manuscripts, investigator brochures)
  • Conducts QA/QC reviews of bookmarks and hyperlinks
  • Reviews document content for accuracy, completeness and consistency against source documents/data
  • Provides formatting of text and tables for documents authored by Clinical Pharmacology
  • Communicates changes in the documents described above to authors, including CRO personnel, in an effective manner
  • Provides instruction and guidance on templates, formatting, and publishing to CROs
  • Interacts with various departments focusing on document quality (for example, Regulatory Operations and Clinical Quality Assurance)
  • Supports Clinical Pharmacology personnel, as needed, for report management and provides electronic submission training and troubleshooting when necessary
Skills/Knowledge Required:
  • Bachelor s Degree/Life Sciences or related field, or equivalent in industry experience
    Minimum 2 years document management/QC review (content QC) experience
    Minimum 2 years of experience in the Pharmaceutical industry
    Strong PC skills to include: Microsoft Office Suite (Word, Excel, Outlook, PowerPoint)
  • Basic knowledge of document management/quality control, including strong familiarity with clinical documents (for example, protocols, clinical study reports, ICFs, manuscripts)
  • Basic knowledge of clinical development and ICH/GCP preferred
  • Must have strong organization and interpersonal skills, be detail-oriented, be a team player and be willing to work in an environment where individual initiative and accountability to projects are required
  • Must be able to work with limited day-to-day supervision
  • Must have a general knowledge of SOP standards, and be able to follow SOPs/WPs
  • Must have basic knowledge of computer applications including electronic document management systems such as Documentum or eSubmission
Must have basic knowledge of document formatting/editing/publishing techniques/tools such as TRS Toolbox (formerly ISI Toolbox) and all if its features (for example, creating bookmarks and hyperlinks)

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