Trial Master File Analyst – native French speaker Full Time Permanent

Trial Master File Analyst – native French speaker

Our client, a multinational pharmaceutical company is looking for a French speaker – Trial Master File Analyst, to join their new project.

If you are a native French speaker and would like to join them, don’t wait, and apply NOW!

Location: Cork, Ireland

Salary: €35k – €45k (DOE) + bonus

Relocation assistance for those outsides of Ireland

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

· 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 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 (for the French language market)

· 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.

Clinical Trial Essential Document Responsibilities

· Evaluate and tailor the expected documents (ED) to ensure proper tailoring has been assessed to make a trial-specific TMF.

· Evaluate the TMF records before 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

· Understand, comply, and reinforce local regulations and guidance, organization medical policies and procedures, and good clinical practices (GCP)

Minimum Qualification Requirements:

· 1 year of experience with clinical development processes

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

· Experience in document administration

· Knowledge of Good Clinical Practices

· High attention to detail

· Excellent organizational skills

· Strong written and verbal communication skills in both English and French