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
· 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
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