Regulatory Documentation Specialist (Trial Master File Management)

  • Temporary/Contract Positions
  • Northern, NJ

Title: Regulatory Documentation Specialist (Trial Master File Management)

Term: anticipated 1 year

Location: Bergen County NJ (must be on site daily)

 

The Role:

TMF Specialist – Global Regulatory Operations Department

  • Perform daily Trial Master File management activities such as Review, Processing, Filing of Clinical Trial Master File documents, to ensure the TMF is Inspection Ready.
    • Conduct Quality Control reviews of TMF Documents. Coordinate with eTMF vendor for TMF set-up and processing of TMF documents and conduct eTMF query resolution.
    • Assist in the archiving of TMF documents; this may include shipping, retrieval, and tracking of documents approved for archiving to off-site storage; Maintain electronic logs which contain the location of study documents.
    • Development/Contribution toward user manuals / Best Practice guides.

Required:

  • Must have strong document management skills, including experience with review of Regulatory Documents,
  • Must be detail oriented, organized, quality driven and able to work in a team environment under tight deadlines.
  • Knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred.
  • Working knowledge of Microsoft Word, Microsoft Excel, Adobe Acrobat, and electronic document management systems, preferably Documentum. Agility with ClinOps databases preferred.
  • Basic knowledge of CFR, GCP & ICH Guidelines.
  • 2 plus years Pharma experience (includes CRO / Vendor experience).
  • Knowledge and understanding of DIA TMF Reference model
  • Excellent written, verbal, and interpersonal communication skills.
  • Bachelor’s Degree preferred.
  • Accepted file types: doc, pdf, txt, docx.