Associate eTMF Specialist TKPHJP00001277 (m/f)

REFERENZNUMMER:

370101/11

IHRE AUFGABEN:

-Perform an ongoing technical quality control of the eTMF for documents uploaded by Development and other functions based on guidelines provided
-Ensure quality control completion in the system
-Escalate to the document owners or relevant functions any limiting factors and non-compliance related to the eTMF quality and may provide guidance on issue resolution
-Monitor the eTMF quality control completeness and follow up with the document owners or relevant functions until their resolution
-May arrange secure shipments of wet-ink documents

IHRE QUALIFIKATIONEN:

-Basic practical knowledge of TMF processes and its quality control guidelines
-Basic understanding of ICH-GCP quality standards and good documentation practice
-IT literacy, proficiency with Microsoft Office applications; practical experience with the electronic Trial Master File is not essential
-Ability to work on multiple studies simultaneously
-Pre-university education or Bachelor degree
-Fluency in English, spoken and written
-Good self-organization, time management skills, independent and structured way of working
-Problem solving skills

WEITERE QUALIFIKATIONEN:

Project manager