ID EXISTS
POS 3159
Status 5
DJM 1

TMF Manager Outsourced Studies

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: TMF Manager Outsourced Studies (M/F/*)
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Tasks:
  • Management of Trial Master Files (TMFs) from creation through archival
  • Oversee the process, system and tool landscape that supports the management of outsourced TMFs
  • Promote best documentation practice and provide guidance on document standards according to regulatory standards (GCP)
  • Create and/or update SOPs, Working Practices, Guidance Documents, templates, etc. as applicable
  • Enforce use of standards and adherence to quality by providing training and support to business functions
  • Coordinate eDMS Super/Key User community
  • Act as Business Administrator in the electronic Document Management System (eDMS)
  • Act as Business Lead to manage the implementation of a Next Generation DMS
  • Coordinate and participate in system testing activities such as User Acceptance and Performance Qualification Testing
  • Support the design of TMF training concept(s) and training material
  • Ensure Compliance of TMF relevant documentation as well as efficiency of related processes
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Qualifications:
  • Start: asap / Duration: 24 months + / Capacity: full-time / Location: Greater area Basel
  • Minimum Bachelor’s Degree in Life Science/Healthcare or equivalent 
  • Thorough knowledge of clinical Trial Master File (TMF) process with outsourced studies, regulatory requirements and Good Clinical Practice (GCP)
  • At least 5 years in clinical trials & clinical development on study management level
  • At least 3 years working experience with document management systems (DMS)
  • Advanced knowledge of clinical documentation and reporting 
  • Experience on sponsor side and/or expert in CRO (TMF in project management)
  • Knowledge of the national and international data protection legislation
  • Business fluency in English, German is an advantage
Bemerkungen: WANTED: TMF Manager Outsourced Studies (M/W/D). Please contact: +49 89 18 90 998 30 or maria.haushofer@k-recruiting.com Skills: Clinical Data Management, Clinical Development / Study Design, Clinical Operations, English, GCP (Good Clinical Practice), Pharma
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Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 24 months +
Einsatzort: Greater area Basel
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