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Clinical Study Manager

  • Danaher
  • 1000København K,Danmark
  • 04/01/2023
Fuldtid

Jobbeskrivelse

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career. Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. The is known for its scientific curiosity and ability to understand different therapeutic areas as well as collaborating with a cross functional team. Radiometer has a diverse and technologically advanced line of Medical Devices that is used for diagnosing a broad group of patients worldwide. You will have the opportunity to lead and execute clinical studies, collaborate with doctors and nurses to identify which sites are most suitable to conduct studies with. Furthermore, you can look forward to being a key contributor internally when you communicate the progress of clinical studies to key stakeholders. In this role, you will have the opportunity to: Manage global clinical studies and programs associated with all RMED's business areas to support global registrations Lead the Study team and collaborate with other functions as well as external partners on clinical study deliverables Proactively identify clinical project risks, provide input to appropriate countermeasures and contingency plans, and assure implementation of action plans to reduce project risk and meet clinical study timelines The assignments require you to maintain knowledge about clinical input required by European regulators, ISO, FDA and Good Clinical Practice (GCP). You also get to collaborate cross-functionally with data managers, regulatory, quality, R&D, Marketing and Operations. Collaboration with external partners such as investigators, subject matter experts and Contract Research Organizations on product development process deliverables are also part of the job. The job requires travelling up to 40% of your time. The essential requirements of the job include: Bachelor of Science (B.Sc.) or Master of Science (M.S.) in a scientific, biological, or medical science discipline is required. This combined with the following increases your chances of success in the job: More than 5 years of experience in leading clinical study execution as a Clinical Study Manager Knowledge of how to apply clinical development expertise to create excellent clinical protocols Experience with successful proactive planning and leading clinical study execution for clinical diagnostics and/or medical devices in a regulated environment Demonstrated solid track record of successful results and in leading collaboration in effective teams and getting work done through others Demonstrated strong ability to understand complex scientific, engineering and business concepts Clinical experience with Blood Gas testing, Transcutaneous Monitoring and Immunoassays testing is an advantage. Hybrid At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide. Application We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application. We encourage you to apply before end of business on 8th January 2023. If you have questions, feel free to contact Chief of Clinical Affairs & Bioinformatics, Lisbet Bærentzen at lisbet.barentzen@radiometer.dk. We look forward to seeing your application. We thank you for your interest. Please read our Applicant Data Privacy Notice carefully Danaher When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization. At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. If you’ve ever wondered what’s within you, there’s no better time to find out.