Trial Master File Projects Associate – fluent in FRENCH

Location: Cork, Ireland

Requirements: EU/UK Passport or Irish Stamp 4

· 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

· 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

· 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.

Requirements:

· Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development, preferred.

• 2 years’ experience with clinical development processes, preferred

· Experience in document administration.

· 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.

• fluency in FRENCH is required