Trial Master File Specialist

A company is looking for a Trial Master File (TMF) Specialist in Oncology.

Key Responsibilities

Ensure quality, maintenance, and completeness of Trial Master Files

Identify trends or quality concerns and oversee resolution of issues with the TMF Process Owner

Collaborate with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements

Required Qualifications

BA / BS with a minimum of 3 years of clinical research experience in academic and / or industry settings

Knowledge of and direct experience with Trial Master Files

Prior eTMF administration required

Strong Microsoft Office skills required

Comprehensive knowledge of Good Clinical Practice and Good Documentation Practice