Title: TMF Specialist
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
- 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.