TMF Quality and Process Compliance Manager NOVJP00029693 (m/f/d)

REFERENCE NUMBER:

404193/29

MY DUTIES:

-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 Novartis 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 across Novartis 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 Novartis 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 Novartis SOPs
-As a TMF Operational Excellence representative, may participate in global cross-functional business process performance or clinical development improvement initiatives

MY QUALIFICATIONS:

-Bachelor’s degree in life science/healthcare is required with experience in clinical development and experience 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. Novartis experience in these areas is preferred
-Excellent understanding of system data structures and Clinical Document Management System functionality
-Excellent attention to accuracy and detail
-Excellent communication, organization and tracking skills
-Strong operational skills and demonstrated ability to meet timelines
-Proven networking skills and ability to train colleagues

MY BENEFITS:

-A city with a high quality of life that perfectly embraces both modern and traditional values
-A highly motivated team and an open way of communication
-A very renowned company

PROJECT INFORMATION:

-As a modern company, our client manages to constantly develop further and break new ground.

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.