TMF Projects – French or Polish Speaking

Core Competencies:

1. Clinical/ Pharmaceutical experience
2. Document Management experience
3. Native/ Fluent French or Polish

• 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).
• Assists 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.
• Provide support with TMF Operations administrative activities such as TMF open office hours, meetings agendas/minutes, etc.
• Provide support to ongoing and ad-hoc TMF projects and initiatives.

• 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.
• Identify, communicate, and resolve issues.
• 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, and reinforce local regulations and guidance, company medical policies and procedures, and good clinical practices (GCP)
• Ensure inspection readiness through a complete, accurate and readily available Trial Master File.

• Day-to-day proficiency in one or more of the following language: French.
• Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development, preferred.
• 0-2 years’ experience with clinical development processes, preferred
• Experience in document administration.
• Knowledge of cGCP.

• 1-2 years TMF experience.
• Experience in working with electronic trial master files strongly preferred.
• Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired.
• Ability to learn and comply with regulatory requirements and internal policies.