TMF Operational Excellence Communication and Training 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 Operational Excellence Communication and Training for a 12-months contract to be based in Basel Switzerland. As an ideal candidate you should have more than 5 years of experience in clinical development in global clinical operations or clinical systems management.
As a TMF Operational Excellence Communication and Training, you will be responsible for the development and implementation of the communication and training campaign on Clinical Documentation including Trial Master File within the company organization under the leadership of the TMF Operational Excellence Head.
- Support the TMF Operational Excellence Head to define the document management training and communication strategy for the Clinical study documentation including the Trial Master File, and the oversight of the process, systems and tools for Headquarters and Country Organizations;
- 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 internal SOPs;
- Develop training material, provide training, coaching of knowledge and experience to enhance expertise of fellow company colleagues;
- Support, attend and present TMF trainings in multiple forums across different line functions;
- Collaborate with training teams in different line functions to deliver training as appropriate;
- Organize regular Q&A sessions on TMF Processes, Systems and tools (eg eTRAC, TMF TOC, VirtualTOC, Document Management System);
- Serve as a liaison between process end-users and eDMS / TMF Governance and Management teams to drive user needs assessment workshops, technical solution discussions and implementation plan;
- Ensure best practice sharing and promote awareness.
Qualifications and Experience:
- Bachelor’s degree required; Advanced degree in life science preferred with minimum 5 years’ experience in clinical operations and / or clinical document management;
- Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice;
- Excellent understanding of system data structures and Clinical Document Management System functionality;
- Ability to learn new systems readily;
- Resolve issues with minimal supervision and understand when to escalate;
- Fluency in English;
- Relevant working/residency permit or Swiss/EU-Citizenship required.