(Junior) Study Manager (m/f/d)

We are MIETHKE, a global medium-sized medical technology company based in Potsdam. As a technology leader in the field of neurosurgery implants, we develop and manufacture highly specialized solutions for the derivation of brain water – with precision, innovative strength and responsibility for our patients suffering from hydrocephalus. Our particularly high production depth is a central success factor.

As part of our Clinical Scientific Affairs team, you support the planning, implementation and follow-up of clinical activities within the framework of a project for the approval of a new product and thus make an important contribution to ensuring regulatory requirements.

Be part of our versatile team: You want to design, take responsibility and work at eye level in an environment? Then you're right with us. We are looking for a dedicated personality with an analytical sense of shame, structure in thinking and lust for responsibility.

And: Diversity, appreciation and tolerance are part of our lived culture – we look forward to meeting your basic values.

You support the planning, implementation and documentation of the clinical trial according to Good Clinical Practice (GCP) and Medical Device Regulation (MDR). You supervise study centres and carry out monitoring activities (e.g. remote and on-site monitoring) to ensure data quality and protocol compliance. You accompany the clinical activities after market launch, in particular in the context of the Post-Market Clinical Follow-Up (PMCF) according to MDR. You create and maintain relevant documents and documents, e.g. in electronic systems such as EDC/eCRE platforms. You support comprehensive clinical project management, systematically track measures and carry out regular on-site visits in clinics for monitoring, training and study coordination.

completed studies in the field of life sciences, medical technology, pharmacy or comparable first practical experience in clinical studies or clinical affairs in medical technology Basic knowledge of Good Clinical Practice and first understanding of regulatory requirements (e.g. MDR, ISO 14155) Experience in handling clinical tools and data management systems (EDC/eCRF monitoring software) structured, careful and self-sponsored working and high organisational capacity strong communication and team skills very good knowledge of German and English as well as willingness to attend on-site visits to study centres

a working environment in an innovative, medium-sized company with over 250 employees and interesting and varied tasks family-friendly and flexible working time models and a workplace where we can be ourselves a temporary employment relationship for three years with a clear interest in a period of time for a certain economic situation Possibility of occupational pension provision, further qualification by the possibility of participation in training events sports offers and team events as well as coffee specialties, tea and water at any time, but also a lot more