TMF Lead II

A company is looking for a TMF Lead II.

Key Responsibilities :

Manage and support the Trial Master File (TMF) throughout the lifecycle of clinical studies

Ensure TMF health, completeness, and compliance with ICH / GCP guidelines

Oversee the preparation of the TMF for audits and inspections, and maintain audit readiness

Required Qualifications :

BS / BA degree in a related discipline with 6-7 years of experience, or MS / MA degree with 3 years of experience, or equivalent combination of education and experience

Minimum 7 years of experience in a clinical research environment

5+ years of experience in TMF management

Clear understanding of GCP and ICH guidelines

Knowledge of regulatory / clinical document requirements and proficiency in Microsoft Office and related software