vor 5 Tagen

Clinical Trial Master File (TMF) Quality and Compliance Manager

Kelly Scientific Resources KSR Basel

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Clinical Trial Master File (TMF) Quality and Compliance Manager

Our customer, a leading international pharmaceutical company with headquarters in Basel, is looking for a motivated
 
Clinical Trial Master File (TMF) Quality and Compliance Manager
 
In this role, you will be responsible for the monitoring of Trial Master File (TMF) process compliance using metrics, while ensuring optimal functioning of TMF processes and systems to support business deliverables and meet Health Authority requirements.
 
Your main tasks:

  • 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
    • Conduct periodic evaluation of the KPIs/KQIs and reporting capabilities
    • Track progress to KPIs/KQIs, and overall compliance to TMF processes
    • 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
  • Proactively partner and successfully collaborate with key stakeholders and support TMF user community to achieve KPIs/KQIs related to the TMF
  • Support 100% inspection readiness at all times by contributing to the overall inspection readiness strategy and proper planning of TMF self-assessment and periodic reviews in close collaboration with the TMF Governance and Management team
  • Track recent TMF audit and inspection findings to ensure proper oversight by CDGM across the portfolio. Contribute to the identification of lessons learned from audits and inspections. Collaborate with the TMF Operational Excellence Communication and Training managers to share learnings from TMF related audit and inspection findings with the TMF user community
  • 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
 
Your background:
 
  • University degree in a Life Science field (e.g. pharmacy)
  • Work experience in Clinical Development (e.g. at a CRO or at a pharmaceutical organization)
  • Previous experience with TMF and excellent understanding of system data structures and Clinical Document Management System functionality is a must
  • Experience in collaborating with global cross-functional multicultural and international teams
  • Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice (GCP)
  • Excellent attention to accuracy and detail, as well as excellent communication, organization and tracking skills
  • Proven networking skills and ability to train colleagues
  • Fluent English (oral and written)       
 
Assignment start: asap
Assignment duration: 1 year
Workload: 100% (40h/week)
Workplace: Basel
 
What our client offers: As part of a highly prestigious, multinational environment you will have the chance to contribute towards developing new medicines to safe people's lives.
 
If you have the required experience and if you would like to apply for this interesting position, please send your complete application documents (CV, testimonials, diplomas) to janine.cabrera(at)kellyservices.ch or apply online.
We are looking forward to getting to know you!