#Innovation #Teamwork #Initiative are our shared values. If you are looking for a meaningful challenge in an established and fast-growing international company, join our team and help us save lives every day.

Penumbra Europe GmbH, based in Berlin and headquartered in Alameda, California, is a global healthcare company focused on innovative therapies for stroke patients. Penumbra designs, develops, manufactures, and markets novel medical technology products with a diversified portfolio. With 4,500 employees worldwide and a revenue of $1.2 billion in 2024, our customers include hospitals and healthcare providers through direct sales in the United States, Europe, Canada, and Australia, as well as through distributors in select international markets.

Are you ready to take the lead in advancing innovative medical technologies that improve patient outcomes? Join our team at Penumbra as a Clinical Study Manager (m/f/d) and play a crucial role in the execution, planning and management of clinical studies across the EMEA region.

As a Clinical Study Manager (m/f/d), you will drive the success of our clinical studies from start to finish. You will be the key contact for internal and external stakeholders, ensuring that all study-related activities are executed according to timelines, regulations, and company standards.

What’s In It For You

• Stay Active – Enjoy an annual fitness subsidy to support your healthy lifestyle.
• Support & Well-Being – Benefit from our comprehensive Employee Assistance Program, providing guidance and support in times of need.
• Family First – Receive two weeks of paid Family Care Leave to support a sick family member or in the case of bereavement.
• Vacation Time – In addition to your regular vacation days, enjoy paid time off on December 24th and 31st.
• A Team That Inspires – Work alongside a diverse, open-minded, and supportive team that encourages personal and professional growth.
• Boost Your Investments – Take part in our Employee Stock Purchase Program and enjoy 15% cashback on your investments.
• Accident Insurance – Stay protected with comprehensive accident insurance during all business trips.
• Location Specific Benefits

Main Responsibilities

• Develop and maintain project timelines from study start-up through completion, including database build, data snapshots, and regulatory submissions.
• Lead the development, approval, and distribution of study-related documents such as protocols, case report forms, and study manuals.
• Manage the distribution, collection, and tracking of regulatory documentation to ensure audit readiness at both site and headquarters level.
• Negotiate study budgets with investigational sites, Core Labs, and other vendors.
• Act as the primary contact for vendor management including Core Labs, ensuring service delivery according to agreed timelines and budgets.
• Oversee and organize Investigator Meetings in collaboration with internal and external stakeholders.
• Monitor the progress of studies, identify study-related trends/issues, and implement corrective actions when necessary.
• Support internal and regulatory audit activities and ensure compliance with quality management systems and regulatory standards.
• Assist with regulatory submissions and the preparation of clinical study reports.
• Forecast study timelines and budgets, ensuring studies are executed on time and within financial parameters.
• Evaluate, analyze, and interpret clinical study data and present findings in well-organized, scientifically sound reports.

What We’re Looking For

• 3 years of experience in clinical trials within the medical device, pharmaceutical, or life sciences industry, with a strong understanding of CFR, GCP, and ICH regulations
• Bachelor’s degree in Life Sciences, Nursing, or a related field
• Experience in peripheral vascular or related disease areas (e.g., Pulmonary Embolism, Acute Limb Ischemia, or Venous Thrombosis).
• Proven expertise in vendor management, budget negotiations, and clinical trial documentation
• Proficiency in EDC systems, study management tools, and Microsoft Office
• Strong organizational and communication skills, with the ability to manage multiple projects simultaneously
• High attention to detail, problem-solving abilities, and a focus on accuracy in data management and reporting
• Fluency in English (additional European languages are a plus), with a solid working knowledge of medical terminology
• Field experience and ability to travel internationally as needed

As we require fluently English skills and the process will involve English speaking colleagues, we are looking forward to receiving your CV in English.

At Penumbra, we value your skills and qualifications above all else. We welcome candidates of any gender, ethnicity, religion, sexual orientation, or age. If you’re skilled and a good match for our culture of collaboration, we want you on our team.

To learn more about Penumbra’s commitment to being an equal opportunity employer, please take a look at our AAP-Policy-Statement.