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Archiviertes Projekt - Clinical Documentation Compliance Manager

Mai 2019

Mai 2021

CH-Basel

auf Anfrage

14.03.2019

122999_1552576394

Projektbeschreibung

For our Global Pharmaceutical Client we are recruiting for a Clinical Documentation Compliance Manager who will oversee the adherence and compliance of TMF data according to Global Clinical Regulations. This position sits within the Clinical Document Governance and Management team and reports to the TMF Operational Excellent Head.

Responsibilities:

* 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

Requirements:

* 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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