TMF Quality and Process Compliance Manager
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organization focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for an enthusiastic TMF Quality and Process Compliance Manager for a 12-months contract to be based in Basel Switzerland. As an ideal candidate you should have 3-5 years of experience in clinical development in global clinical operations or clinical systems management.
As a TMF Quality and Process Compliance Manager, you will be 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.
- Responsible for monitoring overall compliance with TMF processes using functional metrics related to TMF;
- Collaborating with line functions and the TMF Governance and Management team to develop KPIs/KQIs to measure quality and completeness of TMFs;
- Conducting periodic evaluation of the KPIs/KQIs and reporting capabilities;
- Tracking progress to KPIs/KQIs, and overall compliance to TMF processes;
- Identifying and escalating trends/metrics to relevant representatives to develop remedial actions;
- Supporting compliance and overview of mandatory TMF training;
- Supporting in full 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;
- Tracking recent TMF audit and inspection findings to ensure proper oversight;
- Contributing to the identification of lessons learned from audits and inspections;
- Collaborating with the TMF Operational Excellence Communication and Training managers to share learnings from TMF related audit and inspection findings with the TMF user community;
- Promoting best documentation practice to line functions to ensure that documents created in the course of clinical research are managed and archived in accordance with GCP guidelines and SOPs;
- Participating in global cross-functional business process performance or clinical development improvement initiatives.
Qualifications and Experience:
- Bachelor’s degree in life science/healthcare;
- 2-5 years of experience in global clinical development with 2 years in clinical systems management;
- Ability to work both independently and in a global cross-functional 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;
- Strong operational skills and demonstrated ability to meet timelines;
- Proven networking skills and ability to train colleagues;
- Fluency in English;
- Relevant working/residency permit or Swiss/EU-Citizenship required.