The Associate- Trial Master File Project serves a key role in the execution of TMF Operations processes and administration. Provides process support for TMF creation, maintenance, closure, and archival. Provides support for TMF Operations to resolve any issues identified with the TMF activities. Works with study teams and functions to help mitigate issues, identify impact to applicable internal processes, and support process improvements. Executes change management oversight to ensure consistent application of revised standards, processes, and systems functionality across study teams. The TMF Project Management Associate will ensure the TMF for the clinical trial(s) are inspection ready through a complete, accurate, and readily available Trial Master File.

Responsibilities:

• Serve as TMF subject matter expert.
• Partner with internal colleagues to develop and execute metrics to demonstrate control of the TMF process.
• Support internal audits and external inspections, as appropriate (e.g., a table of contents based on the trial-specific TMF Expected Document Lists (EDLs).
• Assisting TMF Process Specialist with providing process and planning support to study teams with TMF-related remediation and process execution as needed.
• Handles eTMF process-related questions and answers.
• Providing support with TMF Operations administrative activities such as TMF open office hours, meeting agendas/minutes, etc.
• Provide support to ongoing and ad-hoc TMF projects and initiatives.
• Define, manage, and execute TMF implementation plans for the trial from start-up to close-out.
• Communicate global internal/external requirements relating to the TMF during collaborative functional meetings.
• Collaborate and influence functional representatives and record owners to ensure TMF remains complete, current, and correct.
• Identify opportunities to share learning to the functions as appropriate.
• Assists with TMF process education efforts.
• Support integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices.
• Assist, as needed, with eTMF configuration testing
• Evaluate and tailor the expected documents (ED) to ensure proper tailoring has been assessed to make a trial-specific TMF.
• Evaluate the TMF records prior to finalization, as appropriate.
• Communicate directly with functional areas for proper hands-off to occur during the start-up, maintenance, and close-out of the trial.
• Ensure appropriate functional check oversight activities occur for all functional areas.
• Ensure appropriate archiving of clinical trial documents to meet the company’s record retention policies and regulatory requirements.
• Understand, comply with, and reinforce local regulations and guidance, the company’s medical policies and procedures, and good clinical practices (GCP)
• Being inspection ready through a complete, accurate, and readily available Trial Master File

Requirements:

• 1-2 years’ experience with clinical development processes or trial master file or clinical trial experience
• Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable
• Fluency in Italian
• Knowledge of cGCP
• Proficiency with MS Office/Adobe Acrobat
• Experience in working with electronic trial master files is strongly preferred
• 1-2 years TMF experience a plus
• Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired