AdresseWe are looking for a Clinical Operations Manager (m/w/x) to support us in our mission with immediate effect.
You will be taking ownership to coordinate, execute, control and complete all of our clinical operations, including clinical trials. We are currently conducting several clinical trials in order to make our digital medical devices “Cara Care für CED” and “Care Care für Sodbrennen” prescribable and fully reimbursable via the German DiGA pathway.
Being the main driver of these trials, your work will have great impact on the business and the lives of thousands of patients from different GI indications, including chronic-inflammatory bowel diseases and upper GI conditions. You will have the opportunity to experience exciting challenges on a daily basis that help you grow personally.
Your Responsibilities
- You are responsible for the project management and administration of clinical trials of medical devices (define, drive and track study timelines, milestones and costs)
- You develop, review, and edit clinical trial related documentation (study specific documents, handbooks, guidelines, checklists)
- You provide support in the conduction of site selection, study initiation, interim monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) regulations and standard operating procedures (SOPs)
- You disseminate clinical trial related information including project tracking updates to relevant other departments
- You act as the central contact for the medical team and trial sites for designated project communications, correspondence, and associated documentation
- You prepare and coordinate specified clinical trial meetings (investigator meetings, medical team meetings) and create and distribute meeting agendas and minutes
- You support the medical team in ethics and regulatory submissions: Collect, create, andreview essential documents for proper content, liaise with clinical trial sites to resolve outstanding issues
- You contribute to the development of regulatory documents, responses to clinical trial related authorities
- You address enrollment and retention issues, identify and implement actions to keep the study on track
Your Profile
- Education: University degree in (life)science (e.g. Biomedical Science, Biology, Biochemistry); experience in a health-related field is a plus
- 2+ year experience executing clinical trials, Data Management or Clinical Monitoring in a pharmaceutical, CRO or medical device company; experience with medical devices is a plus
- Prior experience in general remote site management activities and clinical trial administrative tasks
- Languages: fluent English and German (C1 level)
- Sound knowledge of GCP guidelines; knowledge of ICH guidelines and ISO14155 is a plus
- Strong project management skills, including attention to detail and the ability to prioritize tasks effectively
- Excellent communication and interpersonal skills, flexibility and ability to work independently
- Work in a reliable, precise, and solution-oriented way
- A high independence and hands-on mentality
- Curiosity to work in the new and rapidly evolving field of digital therapeutics
In return we will ensure you have:
- Great team spirit: a vibrant team and a friendly working atmosphere + regular team events
- Hybrid work setup: you prefer to work from home or remote from somewhere else or want to come to our office in the heart of Berlin and enjoy some company with your colleagues? Choose whatever works best for you, we have a flexible hybrid work setup.
- 30 days off per year: we believe that regular breaks are important and therefore offer 4 additional company wide mental health days on top of the 26 regular holidays
- Support for your mental wellbeing: we offer access to nilo.health, a platform to support your mental wellbeing, including 8 sessions with a psychotherapist or coach per year
- Flexible working hours: an early start into the day or late finishes, you decide
- Impact: your contribution matters - the ability to significantly influence the direction of our startup
- Fair Compensation: competitive salary with regularly salary reviews and equity option + the best equipment to be productive
About Cara Care
Cara Care is an app that provides holistic support for people with digestive issues. Cara Care puts each affected individual into focus. With the help of Cara Care, individuals are able to identify factors that influence their symptoms. They also receive personalised recommendations and exercises - backed by science.
By downloading the Cara Care app, individuals can choose from three medical devices to receive support for conditions such as irritable bowel syndrome (Cara Care for IBS), inflammatory bowel disease (Cara Care for IBD), or heartburn-related indications (Cara Care for Heartburn). With Cara Care for IBS being approved by the German Federal Institute for Drugs and Medical Devices as a digital health application, individuals are now able to profit from the first reimbursable digital IBS therapeutic.
What it is like to work with us
We are an interdisciplinary team of doctors, designers and software engineers who are all passionate about what we are building and how it can help people. Our work is inspired by our patient’s journey and our actions are focused on impact and results. We thrive in a dynamic, fast-paced work environment, while appreciating what it means to be healthy and well.
To learn a bit more about our motivation, our team and company, you can visit our career page: https://cara.care/de/careers/
At Cara Care we care about equal opportunities
Diversity is important to us. We need a team with all kinds of different perspectives, experiences and backgrounds. That's why we're committed to hiring people regardless of race, religion, colour, national origin, sex, sexual orientation, gender identity, age or disability.
We understand that applying for a new job takes a lot of work and we really value your time. Our team is looking forward to reading your application!
Job Type: Full-time
Language:
- English (Required)
- German (Required)
Work Location: Remote
