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Polish fluent TMF Project Associate

Polish fluent TMF Project Associate

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  • Permanent
  • Cork, Ireland
  • 40-45K p/y USD / Year

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.



  • 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.


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Job Overview
Category not defined
Offered Salary
40-45K p/y
Job Location
Cork, Ireland
Job Type