Clinical Review Nurse for Documentation and Reporting of Clinical Studies

Do you have experience from the healthcare world? And would you like to use your knowledge in a role where you contribute to reviewing data from clinical studies and ensure that our products meet current requirements and regulations? Here, you will play a crucial role in getting our products to market and making a difference for patients worldwide.

Welcome aboard!

As a member of the Clinical Review team, you will work closely with two colleagues in our Clinical Affairs department, while also collaborating with 21 team members across Europe and our sister department in the USA. This gives you the opportunity to engage in a diverse, interdisciplinary environment, both within the organization and with healthcare professionals at hospitals across Europe and around the world.

We offer a flexible work setup, with opportunities to work both from home and on-site at the office.

Welcome to Cook Medical – we make a difference every day

Cook Medical develops and produces medical devices within many clinical specialties that are manufactured in specific countries and locations for global distribution.

Responsible, competent, and professional employees are our most valuable resource, and they are at the core of our philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide.

Quality Assurance of Clinical Studies

Your day-to-day responsibilities will involve reviewing data from clinical studies according to the applicable quality procedures, regulatory requirements, and standards for medical devices. You will be dealing with day-to-day oversight that supports our products both before and after they are released to the market.

You may be involved with all types of medical devices in Cook Medical's portfolio, and you will typically handle between 4 to 8 studies, depending on their type and size. Because you follow the studies from start to finish, you will continuously work on various stages of the process and always have the primary responsibility for data review and communication.

Data Review and Identification of Adverse Events

To ensure you ask the right questions and query when information is missing or discrepancies arise, it's essential to stay well-informed about both local and global standards and regulations, such as FDA, ISO 14155, EU-MDR, and Good Clinical Practice. Focusing on clinical studies, your main tasks will be to:

• Ensure that data from clinical studies is accurate and consistent.
• Monitor and identify adverse events in accordance with applicable quality procedures, regulations, and requirements.
• Act as a coordinator when events require further assessment by external committees.
• Work closely with study teams and provide input for study protocols, documentation, and reports.

Hands-on Experience from the Healthcare World

You are likely a trained nurse or hold a similar qualification (e.g., radiographer) and are familiar with following patient journeys before, during, and after surgery or treatment. This experience has given you a solid understanding of the practical processes in the healthcare sector. Additionally, you have good critical thinking skills, a systematic approach to tasks, and the ability to maintain an overview while working with complex projects.

• Experience with clinical studies and data is an advantage but not a requirement.
• You have good collaboration skills and can work both interdisciplinarily and cross-culturally.
• You write and speak both Danish and English at a high level.
• You are familiar with working with various IT tools (Outlook, Office, and likely various internal systems).
• You are curious, proactive, and not afraid to ask questions, contributing to a positive atmosphere with a can-do attitude towards tasks and colleagues.

Cook as a workplace

Cook Medical is a family-owned American company with approximately 11,000 employees worldwide, working every day to develop and manufacture medical devices for minimally invasive surgery, thereby promoting quality of life and life-saving treatment. In Denmark, we are around 750 colleagues based in Bjæverskov and Ringsted who contribute to this.

At Cook Medical, we are proud of our very special "Cook spirit". No matter where you go in the organization, you will be greeted by kindness and pride in the quality of the work we do and the products we create. As a Cook employee, you'll help develop innovative medical solutions – and we know that we make a difference for people around the world every day.

We value qualities such as determination, loyalty and humor and work for an open dialogue. As a new Cook colleague, you will undergo a well-planned, internal training course, so you quickly gain in-depth knowledge of the company, the products and your colleagues. In addition to a salary package with bonus and pension, we offer a high degree of flexibility in the planning of your work with the task in focus, equipment for working from home, a good canteen arrangement when you are on site, health insurance and activities such as Art Association and Sports Association and free use of the company's own gym.

Are you interested?

If you recognize yourself in the role, send us your application and CV today via the link. If you have questions about the job, you can contact the Team Lead, Clinical Safety Review & Reporting, Maria Buchholtz Fredericia at +45 4195 4274 or Maria.Fredericia@cookmedical.com.

Please apply for the position as soon as possible and no later than Sunday, March 9^th, 2025.

We look forward to hearing from you!