Trial Master File Project Associate – fluent French
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.
· 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