Description:
Our client, a global pharma company are currently recruiting for a fluent German speaking TMF Project Associate to join their Clinical Development team on a permanent basis. As TMF Project Associate you will ensure the TMF for the clinical trial(s) are inspection ready through a complete, accurate and readily available Trial Master File. TMF experience is desirable but not essential for this role, however experience in the clinical development process for this role is required.
- 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)
- Assist TMF Process Specialist with providing process and planning support to study teams with TMF related remediation and process execution as needed
- Handle 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 Lilly record retention policies and regulatory requirements.
- Understand, comply, and reinforce local regulations and guidance, Lilly medical policies and procedures, and good clinical practices (GCP)
- Ensure inspection readiness through a complete, accurate and readily available Trial Master File