TMF Specialist

  • Direct Hire Positions
  • REMOTE

Title: TMF Specialist (Regulatory Documentation)

Contract Term: 1 year with potential to extend

Hours: Up to 40 hrs week

Location: NY/NJ/PA/TX: FULLY REMOTE

The role:

  • Responsible for performing global management activities relating to electronic and paper Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
  • Functions may include, but not limited too; eTMF system set-up and maintenance, creation/management of TMF Plan and filing expectations; eTMF query resolution, eTMF user support, and assisting with the oversight of the eTMF vendor; performing quality control reviews of TMFs to ensure they adhere to SOPs and meet regulatory requirements and ICH guidelines.
  • This role will be required to work collaboratively across functional areas and contribute to positive team relationships, both locally and globally.

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.
  • Excellent written, verbal, and interpersonal communication skills.
  • Bachelor’s Degree preferred.
  • 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)

Client requires all contractors providing services to Client to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date to their employer/supplier, to the extent permitted under applicable law. This requirement is a condition of providing services to Client.