Stellen Detail, K-Recruiting - DIE BESTE LÖSUNG ODER NICHTS.
Stellen Detail, K-Recruiting - DIE BESTE LÖSUNG ODER NICHTS.
Stellen Detail, K-Recruiting - DIE BESTE LÖSUNG ODER NICHTS.
ID EXISTS
POS 3487
Status 5
DJM 1

TMF Quality and Process Compliance Manager

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: TMF Quality and Process Compliance Manager (M/F/*)
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Tasks:
  • Responsible for monitoring of TMF process compliance using metrics, while ensuring optimal functioning of TMF processes and systems to support business deliverables and meet Health Authority requirements
  • Core member of the TMF Operational Excellence team, responsible for monitoring overall compliance with TMF processes using functional metrics related to TMF
  • In collaboration with line functions and the TMF Governance and Management team develop KPIs/KQIs to measure quality and completeness of TMFs
  • Identify and escalate trends/metrics to CDGM representatives to develop remedial actions.
  • Support root cause analysis (e.g. re-training, process change, system/tool enhancement etc..)
  • Support compliance and overview of mandatory TMF training
  • Promote best documentation practice to line functions to ensure that documents created/generated in the course of clinical research are managed and archived in accordance with GCP guidelines and SOPs
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Qualifications:
  • Start: 01.03.2020 // Duration: until 28.02.2021 (1 year contract) // Capacity: 40 h/week onsite
  • Bachelor’s degree in life science/healthcare is required with 3-5 years of experience in clinical development with a minimum of 2 years in global clinical research/clinical operations and/or clinical systems management
  • Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice.
  • Experience in clinical development process is preferred.
  • Advanced ability to work both independently and in a global cross-functional multicultural and international team
  • Excellent understanding of system data structures and Clinical Document Management System functionality
  • Business Fluency in English
Bemerkungen: WANTED: TMF Quality and Process Compliance Manager (M/F/*). Bitte nehmen Sie Kontakt auf msp@k-recruiting.com or +49 89 18 90 998-93. Skills: Clinical Data Management, Clinical Reports (Trial-, Study-, Summary-, and Evaluation Reports), English, GCP (Good Clinical Practice), Pharma
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Interesse geweckt?
Auf geht's!
Beginn: 01.03.2020
Laufzeit: 12 Months
Einsatzort: Basel
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