Clinical, Regulatory and Technical Operations Associate

Berlin       ·         Full time / Part time / Student 

Your Responsibilities

In general:

• Support our Clinical and Product departments in the smooth running of our current clinical trial
• Interact, coordinate and oversee outcomes across functions
• Actively get involved in the drafting of clinical, regulatory and technical documentation in relation to the clinical trial

In particular:

• Writing and updating of clinical documentation content, as relevant and requested by the clinical trial activities (e.g. clinical brochures, informed consent forms, manuals of procedures) and other clinical and regulatory documentation, as per GCP and company compliance guidelines, under the direction of the clinical trial team
• Write and update parts of our technical documentation (e.g. instructions for use manual, technical change requests and updates, as well as usability engineering)
• Track the submission of formal documentation, e.g. study updates, software updates in different countries and clinical sites, together with clinical, technical and external partner organizations (i.e. CROs)
• Track and coordinate completion of documents translations, where required, with external partners and the trial team
• Support the quality management system (according to ISO 13485), training and development of standard of procedures
• Interact and assist the cross-functional teams in the design and implementation of new processes or initiatives within the clinical department

Your Qualifications

• Academic degree in healthcare or a life science, preferably related to medical technology, medicine or preclinical (animal) research
•  1-2 years of relevant career experience
• A demonstrated ability to write either scientific or formal documentation reports (e.g., lab reports, study reports, articles, publications, dissertations, theses, abstracts)
• Proven record of organizational and project management skills
• Ability to work independently and take ownership and drive of own activities as well as interacting in a team, in a small and startup culture company environment
• Ability to use Office suite tools and writing/ tracking standard tools, e.g. Confluence
• Working proficiency in English

What We Offer

• The opportunity to actively participate, learn and contribute to the activities and the future of an ongoing clinical trial and digital therapeutic device with European operations
• Work directly with and develop your professional skills alongside experienced clinical and health-tech professionals
• Competitive salary
• Flexible working schedule (part-time option)
• You can work in the heart of Berlin, with home office flexibility or the option to work remotely
• Workspace located at Mindspace, the coolest co-working space in the heart of Berlin (easily reached by public transport) with free yoga classes, coffee and happy hours

About Us

Dopavision is a digital-health startup based in Berlin. Our goal is to radically change vision care with digital solutions. We are focusing on myopia, or shortsightedness: 200 million children globally are suffering from progressive myopia and the incidence is rising dramatically across the globe. We have raised funds in a Series A round in 2021 and are supported by Novartis and other investors in the field. 

We are developing a digital treatment to slow myopia progression in children in the form of a smartphone app, to be used with a virtual or augmented reality device. We are conducting a clinical study in a few countries in Europe, while we are continuing the development and optimization of our product.

Please click here to apply.