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

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