(Associate) Clinical Trial Manager (all genders are welcome)

At Ethris, we are working at the forefront of medical innovation and technology. To us, this is a once-in-a-lifetime chance, working on rethinking human therapeutics. We strive towards developing the next generation of mRNA therapeutics and vaccines for respiratory diseases. We're a dedicated and skilled team of around 30 with different cultural backgrounds, all following the goal of revolutionizing medicine and bringing ground-breaking new therapies to patients worldwide in due time. With our truly innovative, self-developed and IP-protected suite of platforms for lipidoid nanoparticle delivery, mRNA design and optimization, mRNA manufacturing and drug product stabilization at room-temperature, we are uniquely positioned to achieve our ambitious goals.

Join our team as (Associate) Clinical Trial Manager (all genders) on a temporary basis for 2 years to cover maternity leave (onsite or remote) , advance your career, and become part of an amazing journey to bring new and breakthrough genetic medicine to patients worldwide.

Our mission

At Ethris, we are working at the forefront of medical innovation and technology. To us, this is a once-in-a-lifetime chance, working on rethinking human therapeutics. We strive towards developing the next generation of mRNA therapeutics and vaccines for respiratory diseases. We're a dedicated and skilled team of around 30 with different cultural backgrounds, all following the goal of revolutionizing medicine and bringing ground-breaking new therapies to patients worldwide in due time. With our truly innovative, self-developed and IP-protected suite of platforms for lipidoid nanoparticle delivery, mRNA design and optimization, mRNA manufacturing and drug product stabilization at room-temperature, we are uniquely positioned to achieve our ambitious goals.

Our offer

As a highly ambitious and thriving biotech company, we offer you an extremely interesting but also demanding job. You will have the opportunity to quickly expand your operational, strategic, and personal skills in a highly motivated team. An open communication culture and working atmosphere combined with a strong team spirit contribute to our success.

Your tasks

• Overseeing daily operations and logistics of one or more outsourced clinical trials, including project planning and coordination of meetings
• Trial status tracking/reporting, risk management activities, monitoring project deliverables and coordinating with internal and external parties
• Management of vendors such as contract research organizations, central laboratories, and other specialty service providers
• Development or review of trial related documents
• Set-up of the eTMF and oversight of filing activities
• Ensuring that all aspects of the assigned clinical trials are in compliance with ICH, GCP and applicable regulatory requirements
• Participating in initiatives ensuring continued operational excellence within the department and company
• Identification, selection and oversight of clinical investigators and trial sites

Your profile

• 4+ years’ experience in clinical trials in the biotech/pharmaceutical industry or at a CRO
• Knowledge of Regulatory Affairs, Data Management, Biostatistics & Pharmacovigilance processes
• In-depth knowledge of Good Clinical Practice, ICH guidelines and regulatory requirements
• Experience in respiratory and/or infectious diseases is a plus
• A good command of written and spoken English
• Excellent interpersonal, written & verbal communication and organizational skills
• A flexible, engaging, friendly and confident personality with a high level of initiative and ability to work independently
• Strong problem-solving skills
• Open-minded, creative and enjoy developing new concepts and strategies
• Strong team player; communication and networking with both internal and external parties is part of your personality

About us

Ethris is located in Munich, a very beautiful, exciting and safe city in southern Germany that offers a particularly high quality of life. The Munich region is considered one of the leading biotech hubs in Europe. Ethris truly benefits from the strong scientific cluster-knowledge in the region, driven by intense scientific exchange and collaboration with Munich’s renowned academic institutions, such as Ludwig Maximilian University, Technical University, Max Planck Institutes of Biochemistry and Neurobiology, and the Helmholtz-Center - as well as with other life science companies.