Regulatory Documentation Specialist (Trial Master File Management)Monday, July 15th, 2019
Title: Regulatory Documentation Specialist (Trial Master File Management)
Term: anticipated 1 year
Location: Bergen County NJ (must be on site daily)
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.
- 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.