TMF Specialist

Title: Trial Master File Specialist (Regulatory Documentation)

Term: anticipated 1 year

Location: Bergen County NJ (commutable candidates only please)

Industry: Pharmaceutical

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, 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.