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
- 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.
- 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.