Clinical Research Associate

vor 4 Wochen

Jena, Thüringen, Deutschland Occlutech GmbH Vollzeit

We are seeking a highly motivated Clinical Research Associate to join our team at Occlutech GmbH, a leading specialist provider of minimally invasive cardiac devices. As a Clinical Research Associate, you will play a key role in the conduct of clinical trial activities, including supporting the submission process, ensuring appropriate documentation, and preparing relevant trial-specific documents and communication with trial sites.

The ideal candidate will have a university degree in life sciences or engineering, at least 3 years of professional experience in clinical research, and knowledge of Medical Device Regulation (MDR). You will also have proficiency with ICH, GCP, and ISO, as well as experience working in a dynamic, international environment. Strong communication skills in German and English are essential, and you will be able to work independently, adapt to changing tasks, and manage multiple tasks.

We offer a comprehensive onboarding and training plan, a company-wide mentoring program, and a healthy work culture with regular team sporting events. Our benefits include a secure job in the medical device industry, an interesting work scope, and a good work-life balance through flexible working hours and hybrid working time models.

Key Responsibilities:

  • Plan, prepare, and manage all monitoring-related activities, including performance of monitoring of trial/registry sites
  • Assist in study audits, as required
  • Main line of communication between investigators/site staff and Occlutech
  • Conduct clinical trials, clinical studies, and registries according to all applicable regulations, commonly accepted practices, and Occlutech's internal guidelines
  • Prepare essential documents according to ISO 14155, MDR, and Care for submission-approvals by Competent Authorities and favorable opinions by responsible Ethics Committees
  • Liaise with study investigators and site staff on a regular basis
  • Oversee and lead subcontractors, such as data management and local monitors
  • Provide regular updates to CRM on trial status, plans, and bottlenecks
  • Contribute to Occlutech's QM system, including preparing SOPs

Requirements:

  • University degree in life sciences or engineering (min. Bachelor's degree, preferably Master's degree)
  • At least 3 years of professional experience in clinical research
  • Knowledge of Medical Device Regulation (MDR)
  • Proficiency with ICH, GCP, and ISO
  • Experience working in a dynamic, international environment
  • Strong communication skills in German and English
  • Ability to work independently, adapt to changing tasks, and manage multiple tasks

  • Clinical Research Associate

    vor 1 Woche

    Jena, Thüringen, Deutschland Occlutech GmbH Vollzeit

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Occlutech GmbH. As a Clinical Research Associate, you will assist in the conduct of clinical trial activities, ensuring compliance with regulatory requirements and company policies.Key Responsibilities:Support the submission process for clinical trialsEnsure accurate...

  • Clinical Research Associate

    vor 1 Monat

    Jena, Thüringen, Deutschland Occlutech GmbH Vollzeit

    We are seeking a highly motivated Clinical Research Associate to join our team at Occlutech GmbH. As a Clinical Research Associate, you will play a key role in the conduct of clinical trial activities, including supporting the submission process, ensuring appropriate documentation, and preparing relevant trial-specific documents and communication with trial...

  • Clinical Research Associate

    vor 4 Wochen

    Jena, Thüringen, Deutschland Occlutech GmbH Vollzeit

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Occlutech GmbH. As a key member of our clinical research team, you will be responsible for assisting in the conduct of clinical trial activities, ensuring compliance with regulatory requirements and providing high-quality support to our investigators and site staff.Key...

  • Field Service Engineer

    vor 4 Wochen

    Jena, Thüringen, Deutschland Danaher Vollzeit

    Diagnostic Systems Installation and Maintenance SpecialistAt Danaher, we're committed to advancing and optimizing the laboratory to move science and healthcare forward. As a Diagnostic Systems Installation and Maintenance Specialist, you'll be responsible for installing, maintaining, and repairing diagnostic systems, immunochemistry, clinical chemistry, and...

  • Clinical Research Associate

    vor 2 Monaten

    Jena, Deutschland Occlutech GmbH Vollzeit

    Clinical Research Associate (m/w/d) Clinical Research We are offering a position in the medical device sector with ambitious and passionate people building meaningful products for patients all over the world. Our work environment is agile and allowing for collaboration with smart people and knowledge sharing in cross functional teams. As a fast-growing...

  • Clinical Trial Assistant

    vor 2 Monaten

    Jena, Deutschland Occlutech GmbH Vollzeit

    **About the Company**: Occlutech is a leading specialist provider of mínimally invasive cardiac devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a global leading specialist provider in cardiac devices, addressing congenital heart defects, stroke prevention, and heart failure. Occlutech has a...

  • Doctoral Research Position As Research Associate

    vor 2 Wochen

    Jena, Deutschland Friedrich-Schiller-Universität Jena Vollzeit

    Job advertisement **Vacancy ID**: 232/2024 **Closing date**: 2024-12-31 Within the framework of the interdisciplinary Research Training Group 3014 “Photo-polarizable Interfaces and Membranes” funded by the German Science Foundation (DFG), the following position is being offered at the Friedrich Schiller University Jena starting as soon as...

  • Clinical Trial Assistant

    vor 2 Monaten

    Jena, Deutschland Occlutech GmbH Vollzeit

    Clinical Trial Assistant (m/w/d) Occlutech is a leading specialist provider of mínimally invasive cardiac devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a global leading specialist provider in cardiac devices, addressing congenital heart defects, stroke prevention, and heart failure....

  • Forschungsstelle für Doktorand:inals wissenschaftliche:r Mitarbeiter:in

    vor 1 Woche

    Jena, Deutschland Friedrich-Schiller-Universität Jena Vollzeit

    Friedrich Schiller University is a traditional university with a strong research profile rooted in the heart of Germany. As a university covering all disciplines, it offers a wide range of subjects. Its research is focused on the areas Light—Life—Liberty. It is closely networked with non-research institutions, research companies and renowned cultural...

  • Field Service Engineer

    vor 6 Monaten

    Jena, Deutschland Danaher Vollzeit

    Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...