TMF Specialist

Title: TMF Specialist
Regulatory Documentation
Term: Anticipated 1 year, potential to extend
Location: Woodcliff Lake, NJ
On-site or Remote position – up to 40 hrs week

The ideal candidate will have:

Basic knowledge of CFR, GCP & ICH Guidelines
2 plus years Pharma experience (includes CRO / Vendor experience)
Knowledge and understanding of DIA TMF Reference model

The Role:

  • 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
  • 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.
  • eTMF/TMF Process and system training
  • eTMF Implementation experience
  • Ability to think outside the box
  • Hands on Inspection experience (FDA, MHRA, etc)
  • Internal audit preparation
  • Support integration of partnered or clinical information including transfer of TMFs in compliance with applicable regulations and best practice
  • Proactively stay current with best practices and recommends application across business groups to improve TMF operations
  • Assist with TMF process education
  • Assist CRO eTMF configuration
  • Assist and deliver key KPI reports to study team, manage expectations, and track on-going KPI across all study team by partnering with clinical operations leads


  • 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.