TMF Lead II

Job Summary

A company is looking for a TMF Lead II - FSP.

Key Responsibilities:

• Manage and support the study TMF throughout its lifecycle, ensuring completeness and accuracy
• Conduct TMF-specific meetings and oversee the planning, set-up, maintenance, and closure of the study TMF
• Monitor TMF health, generate reports, and ensure compliance with regulatory guidelines and internal processes

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 specifically in TMF
• Clear understanding of GCP and ICH guidelines
• Knowledge of regulatory/clinical document requirements and proficiency in Microsoft Office and related software