Project Associate German

 

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

Organization ScientificJobs.ie
Industry Medical / Healthcare
Occupational Category Project Associate German
Job Location Cork,Ireland
Shift Type Morning
Job Type Permanent
Gender No Preference
Career Level Intermediate
Experience 2 Years
Posted at 2022-12-10 5:25 pm
Expires on Expired