TMF Lead II - FSP - US - Remote

Overview

The TMF Lead II is responsible for the completeness and accuracy of the Trial Master File (TMF) for all sponsored studies, providing project management principles for clinical trials and driving inspection readiness efforts.

In Short

• Manage and support the study TMF from setup to closeout.
• Responsible for TMF health and completeness.
• Conduct TMF-specific kick-off meetings with sponsors.
• Oversee planning, maintenance, QC, and closure of the study TMF.
• Ensure compliance with ICH and GCP guidelines.
• Monitor project scope and communicate out-of-scope activities.
• Prepare TMF for QA or sponsor audits and inspections.
• Maintain effective internal and external communication.
• Contribute to business development opportunities.
• Manage complex and large studies.

Requirements

• BS/BA or MS/MA degree in a related discipline.
• Minimum 6-7 years of related experience or equivalent combination.
• 7+ years of experience in a clinical research environment.
• 5+ years of experience in TMF.
• Clear understanding of GCP and ICH guidelines.
• Knowledge of regulatory/clinical document requirements.
• Proficient in Microsoft Office and Adobe Acrobat.
• Preferred: Master’s Degree with a Life Sciences/Business focus.
• Preferred: Experience in clinical electronic systems.

Benefits

• Comprehensive medical, dental, and vision benefits.
• 401(K) plan.
• Paid time off (PTO) – Flex Plan.
• Employee recognition awards.
• Access to multiple employee resource groups (ERGs).