Polish fluent TMF Project Associate

• 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.
• Define, manage, and execute TMF implementation plans for the trial from start-up to close-out.
• Communicate global internal/external requirements as it relates to the TMF during collaborative functional meetings.
• Provide support with TMF Operations administrative activities such as TMF open office hours, meetings agendas/minutes, etc.
• 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 with eTMF configuration testing, as needed.
• 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 company’s record retention policies and regulatory requirements.
• Understand, comply, and reinforce local regulations and guidance, company’s medical policies and procedures, and good clinical practices (GCP)
• Ensure inspection readiness through a complete, accurate and readily available Trial Master File.

Qualifications:

• Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development, preferred.
• 1-2 years’ experience with clinical development processes, preferred
• Experience in document administration.
• Knowledge of cGCP.
• High attention to detail.
• Excellent organizational skills.
• Strong written and verbal communication skills; and Proficiency with MS Office/Adobe Acrobat.
• Demonstrated critical thinking capabilities with forward looking perspective and comfort with ambiguity.
• 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.
• Effective communication, teamwork and problem-solving skills.
• Self-management and organizational skills.

HYBRID MODEL