Archiviertes Projekt - Clinical Documentation Compliance Manager
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* 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
* Support 100% inspection readiness at all times by contributing to the overall inspection readiness strategy and proper planning of TMF self-assessment.
* 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
* 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
* 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
* Advanced Degree in Life Sciences
* 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
* Fluent English (oral and written)
* Advanced ability to work both independently and in a global cross-functional multicultural and international team
* Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice.
* Excellent understanding of system data structures and Clinical Document Management System functionality
* Excellent attention to accuracy and detail
* Excellent communication, organization and tracking skills
We are acting as an Employment Business in relation to this vacancy.
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