Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Radiometer, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. 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. 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. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Clinical Study Manager at Radiometer is responsible for overseeing all aspects of a clinical trial, including developing and implementing study protocols and monitoring plans, selection of clinical sites, driving timelines in coordination with clinical monitoring team, ensuring compliance with SOP and regulatory requirements, and providing regular study progress communication and escalating issues. This position reports to the Sr. Manager or Director of Clinical Affairs and is part of the Clinical Affairs department located in New Brighton, MN and will be an on-site role. In this role, you will have the opportunity to: + Drive clinical schedule deliverables to meet the overall project timelines, influencing internal and external partners to support on-time-delivery through relationship management skills. + Proactively identify clinical project risks, provide input to appropriate countermeasures and contingency plans, and assure implementation of action plans to reduce project risk. + Collaborate with other functions (data management, statistics, medical writing, clinical research, medical affairs, quality, research and development and marketing) as well as external partners (investigators, subject matter experts, Contract Research Organizations) on study deliverables. + Directly participate in shaping clinical study design and completion of study planning deliverables such as development of protocols, monitoring plans, Trial Master File maintenance, budget maintenance, vendor set-up. + Ensure study requirements are met and conducted in a scientifically appropriate and compliant manner not limited to PHI protection, GCP Good Clinical Practices (GCP) and Standard Operating Procedures, investigational-use-only (IUO) product reconciliation activities. The essential requirements of the job include: + Bachelor’s Degree in field with 9+ years of experience OR Master’s Degree with 7+ years of experience OR Doctorate/PhD degree with 4+ years of experience + Knowledge and experience with GCP and global IVD, medical device regulations + Demonstrated agility with processes and details, ability to apply critically thinking, analyze data (using analytical tools), and solve complex problems. + Strong work ethic, ability to work independently and demonstrated ability to deliver assignments on time, and effectively communicate and escalate. + Proficiency in Microsoft Office applications (PowerPoint, Excel, Word) Travel, Motor Vehicle Record & Physical/Environment Requirements: + Able to travel up to 10-25% regionally and internationally. It would be a plus if you can demonstrate: + Knowledge of CLSI guidelines, GCP, GLP, EDC, and eTMF + Clinical research certification (i.e., SOCRA, CCRA, CCRC) + Experience with studies with US FDA submissions and in international settings. The salary range for this role is $135,000 - $150,000 USD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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. The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.