(JUNIOR) STUDY MANAGER (F/M/D)
- Potsdam
- Fulltime
We are MIETHKE, a globally active, medium-sized medical technology company based in Potsdam. As a technology leader in the field of neurosurgical implants, we develop and manufacture highly specialized solutions for the drainage of cerebrospinal fluid - with precision, innovative strength and responsibility for our patients suffering from hydrocephalus. Our particularly high level of vertical integration is a key success factor.
As part of our Clinical Scientific Affairs team, you will support the planning, execution and follow-up of clinical activities as part of a project to secure approval for a new product, thereby making a significant contribution to ensuring compliance with regulatory requirements.
Be a part of our versatile team: Do you want to shape things, take on responsibility and work in an environment of equals? Then you've come to the right place. We are looking for a committed individual with analytical acumen, a structured way of thinking and a desire for responsibility.
And: diversity, appreciation and tolerance are part of our culture - we would be delighted if this also corresponds to your core values.
YOUR TASKS
- You will assist with the planning, conduct and documentation of clinical trials in accordance with Good Clinical Practice (GCP) and the Medical Devices Regulation (MDR).
- You will oversee trial sites and carry out monitoring activities (e.g. remote and on-site monitoring) to ensure data quality and protocol compliance.
- You will support clinical activities following market launch, particularly within the framework of Post-Market Clinical Follow-Up (PMCF) in accordance with the MDR.
- You will create and maintain study-related documents and records, e.g. in electronic systems such as EDC/eCRE platforms.
- You will provide support in cross-functional clinical project management, systematically follow up on actions and conduct regular on-site visits to clinics for monitoring, training and study coordination.
YOUR PROFILE
- A degree in life sciences, medical technology, pharmacy or a related field
- Initial practical experience in clinical trials or clinical affairs within the medical technology sector
- Basic knowledge of Good Clinical Practice and a basic understanding of regulatory requirements (e.g. MDR, ISO 14155)
- Experience in using clinical tools and data management systems (EDC/eCRF monitoring software) would be an advantage
- A structured, meticulous and independent approach to work, as well as strong organisational skills
Excellent communication and teamwork skills - Very good command of German and English, as well as a willingness to undertake occasional business travel for on-site visits to study centres
OUR OFFER
- 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
- an employment relationship initially limited to three years with a clear interest in a permanent contract in a secure economic situation
- the possibility of a company pension scheme, further qualification through the opportunity to participate in further training events
- sporting activities and team events as well as coffee specialties, tea and water at any time, but also much more
INTERESTED?
By the way, we believe that anyone can learn anything. Therefore, please feel free to apply to us if the advertised profile does not seem to suit you completely. We take a close look at every application and are open and curious - even or especially in the case of unusual backgrounds.
If you have any questions about this position, please contact us: +49 331 620 83 4484 or jobs@miethke.com.
Note on our application and selection process:
We highly value diversity. It is therefore a matter of course for us to consider all applications regardless of age, origin, gender, sexual identity, disability or religious affiliation.
- Helmut Tiede
- Recruiter*in
- Florian Drubel
- Director Product Safety & Clinical Affairs
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