Clinical Research Specialist – Post Market Clinical Development – Ambu A/S – Ballerup

Do you have a passion for working with clinical documentation and clinical research globally for medical devices? Are you able to set the strategic direction and take responsibility for executing the clinical activities for our medical devices after Market Launch? Then now a great time to join us in the Post Market Clinical Development Department. A global job with impactWe are searching for a Clinical Research Specialist and in this global position, you will work closely with team colleagues in DK and MY together with other corporate functions and local stakeholders to take clinical lead and provide support in relations to various projects, activities and processes. Your focus will be to coordinate and execute global clinical activities related to maintenance, studies, market entries and expansions in the post market phase of our products.You will be part of an innovative culture focusing on post market clinical activities for a range of our marketed product which means there is a visible link between your results and Ambu’s growth.The position is based at Ambu´s Headquarter in Ballerup, Denmark. As Ambu is a company with worldwide presence, international travelling can be expected as a part of the position.Your responsibilities Take responsibility and ownership as global post market clinical responsible for a range of products and the strategic direction for how we document our medical devices from market launch and throughout the product lifecycle. Develop, maintain, write and review the clinical documentation for the products in the post market phase according to international medical device legislations. Plan and execute Post Market Clinical Follow-up activities.Be a proactive clinical sparring partner in development, maintenance, expansion and improvement projects and activities.Support and continuously improve the strengthening of the clinical commercial foundation for our marketed products within different clinical indication areas.Utilize and balance your clinical scientific focus with a hands-on approach in the clinical activities which you are handling.Be a strong and trusted clinical post market partner in our global organization. Your qualifications Academic degree (MSc in Health, Medicine, Natural Sciences, Engineering or similar qualifications).2-5 years of experience in clinical documentation (CEP, CER, PMCF Plan and Report) for medical devices. In addition, having clinical experience related to our products will be considered an advantage.Competent writing and analytical skills for scientific documentation and literature reviews.Experience in working as the clinical competence within medical device Design Control and Risk Management and Vigilance governed activities.Experience with EU/ FDA legislation, regulations and guidelines related to medical devices and clinical areas. A good understanding of medical device legislations globally could be considered an advantage,Experience with and ability to plan and execute clinical studies for medical devices in the post market product phase and develop and drive post market clinical follow-up strategies.Excellent proficiency in English both written and spoken. Good planning, coordination and prioritization skills.Well versed in Microsoft Office tools (Word, Excel, PowerPoint). Ability to work efficiently both as part of a team with a positive, including and can-do attitude as well as independently being proactive, motivated and a fast learner. Sound people skills, empathic and respectful and lead by passion and example.Personal drive for establishing best practices and solutions within the team and company. As a person you are open-minded and enjoy working in a collaborative environment. Since we are a global company, you will be involved in cross-cultural collaborations. You are curious, highly motivated, and flexible. You have great interpersonal skills and thrive in global teams. You have a passion for new challenges and a well-founded and strong sense of responsibility towards your work. You work in a structured and proactive way with a flexible and able to “think out of the box” mindset.

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