* 5+ years' working experience in clinical operations or clinical document management
* Deep knowledge of clinical development process, regulatory requirements and Good Clinical Practice along with system data structures and Clinical Document Management System functionality
* Strong computer skills, including Excel and MS Word
* Competency to work both independently and in a global cross-functional team with proven networking skills and ability to train colleagues
* Outstanding organisational, tracking and operational skills as well as demonstrated ability to meet timelines
* Bachelor's degree in life science, advanced degree is preferred
* Languages: fluent English both written and spoken
* Being responsible for defining document management training and communication strategy for the Clinical study documentation including the Trial Master File
* Delivering best documentation practice to line functions to ensure that documents generated during clinical research are managed in accordance with GCP guidelines and SOPs
* Creating training material, providing training, coaching of knowledge and experience to colleagues as well as presenting TMF trainings in multiple forums across different line functions
* Maintaining SharePoint including Question and Answer tracker and identifying potential trends along with organising regular Question and Answer sessions on TMF Processes, Systems and tools
* Liaising between process end-users and eDMS, TMF Governance and Management teams to drive user needs assessment workshops, technical solution discussions and implementation plan
Location: Basel, Switzerland
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
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