Senior TMF Manager

A company is looking for a Sr. TMF Manager - Clinical Operations.

Key Responsibilities

Maintain Trial Master Files (TMFs) to ensure they are current and inspection-ready

Lead relationships with Contract Research Organizations (CROs) and manage clinical document quality / control / review

Oversee internal e / TMF applications and perform setup activities

Required Qualifications

Understanding of clinical trial conduct and TMF structure (TMF Reference Model)

Experience with eTMF systems or software

Knowledge of best documentation practices

Ability to develop Standard Operating Procedures (SOPs) and user training manuals

Experience in performing User Acceptance Testing (UAT) and validations