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# Innovation # Teamwork # Initiative are our common values. If you are looking for a meaningful challenge in a well-established international company and if you have a hands-on mentality – then join us and help us to save lives with your know-how and expertise. Be prepared for a career that doesn’t feel like work!
Penumbra Europe GmbH is based in Berlin, headquartered in Alameda, California. We are a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet needs. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, Europe, Canada and Australia, and through distributors in selected international markets. The Penumbra logo is a trademark of Penumbra, Inc.
We are a dynamic and constantly growing company. As a result, we are looking in Germany for an experienced and highly motivated Clinical Research Associate. This is an hybrid position that combines a mix between home office and the willingness to travel nationally (up to 30% of the time). As part of Penumbra’s EMEA Clinical Affairs Team, you will support an innovative and global company that develops ground-breaking technology to further its mission of saving patients’ lives. This is an exciting role where you will have the chance to assist in the planning, design, and execution of clinical studies to assess safety and effectiveness of products. You will work with confidential patients and company datas. You will interface with a variety of internal and external stakeholders. If you want to truly have an impact and make your mark, this is an opportunity for you!
What You'll Work On
- Participate in the monitoring functions in a clinical study including site management, qualification, initiation, routine monitoring and final close out
- Conduct site visits, as necessary. Acting as a company liaison, work with clinical sites to resolve any site related issues quickly and effectively
- Assist Clinical team with the development, approval and distribution of study-related documents including Case Report Forms (CRF's), study protocols, study manuals and other study tools to investigational sites and review committees
- Assist Clinical management with the development, negotiation, execution of the site contract, budget and payment plan
- Draft informed consents with supervision from line manager
- Provide oversight on device accountability, inventory and distribution, device complaint/malfunction processing and tracking
- Based upon Clinical requirements, monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting
- Prepare and participate in presentation of protocols and other study conduct requirements at study initiations including training at investigational sites when needed
- Participate in the distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Penumbra central file and for audit readiness
- Assist with developing/maintaining project timeline, managing study budget and preparing routine operations reports
- Assist Clinical management with regulatory submissions and other reports as required
- Assist with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP's and Work Instructions
What You Bring
- A minimum of 2-3 years’ experience in clinical/scientific research, CRO, nursing or medical devices/ pharmaceutical industry
- Proven clinical monitoring experience and project management experience is preferred
- Excellent communication skills and proficiency in German and English. One further European language is a plus
- Excellent ability to write concise and strategic technical documents
- Demonstrated ability to drive solutions and resolve issues creatively
- You have excellent organization skills and you are able to prioritize and meet deadlines in a fast-paced environment
- Strong hands-on mentality, flexible, open-minded and excellent intercultural skills
- You are ideally based in Germany
- Willingness to travel in Germany (up to 30% of the time)
- Last but not least, you are an excellent team player and thrive when faced with challenges
What We Offer
- Permanent, remote and full-time position. Flexible working hours
- The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases
- The ability to work amongst a professional, dynamic and vibrant global team with friendly, highly qualified colleagues
- Employee stock purchase plan
- Internationally established company with a hands-on mentality, strong emphasis on a diversity culture, positive intercultural environment
Contact
If you are interested in this position, please do not hesitate to apply now. We'd love to hear from you! Jamila Zarra (EMEA Senior Recruiter) will come back to you asap.
Your application will be treated in a confidential, professional and ethical manner.
- Requests from Recruitment Agencies will not be answered -
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