TMF Quality & Process Compliance Manager
A job vacancy for a TMF Quality & Process Compliance Manager has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.
- 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 company 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 the company 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.
- As a TMF Operational Excellence representative, may participate in global cross-functional business process performance or clinical development improvement initiatives.
Skills and Requirements:
- 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.
- 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, organisation and tracking skills.
- Strong operational skills and demonstrated ability to meet timelines.
- Proven networking skills and ability to train colleagues.
- Fluent English (oral and written).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Luke Saner at +44 3300524502 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Ein dynamisches und innovatives Medizintechnik-Unternehmen stellt derzeit einen Mitarbeiter im Raum Stuttgart im Qualitätsmanagement ein (w|m|d).