At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. 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.Beckman Coulter Diagnostics 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 Staff Clinical Compliance Specialist for Beckman Coulter Diagnostics is responsible for Clinical Quality activities across the Global Beckman Coulter Clinical Affairs organization.This position is part of the Clinical Affairs organization located in Chaska MN, Miami FL, and Sacramento CA and will be fully remote. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.You will be a part of the Clinical Compliance team and report to the Director, Clinical Compliance responsible for supporting the compliant conduct of clinical research in a global setting. If you thrive in a fast-paced global role and want to work to build a world-class Clinical Affairs organization—read on.In this role, you will have the opportunity to:
Apply principles of continuous improvement to maintain and update Clinical Affairs procedures based on regulatory updates, internal audit findings and user feedback.
Train Clinical Affairs associates on new or updated regulations, standards, requirements, processes and best practices.
Provide support to clinical study teams and help to troubleshoot clinical compliance concerns.
Leverage the Danaher Business System (DBS – business process improvement tools) to improve efficiency and effectiveness of clinical trials and scientific research through process improvements, systems improvements, use of metrics and dashboards, and other efficiency improvements.
Manage stakeholder communication and interactions with senior leadership, global partners, and cross-functional teams.
The essential requirements of the job include:
Bachelor of Science Degree with 9+ years of experience or a Master’s Degree with 7 years of experience or PhD/MD with at least 4 years of experience
Experience in clinical compliance/clinical quality or management of IVD or medical device clinical studies
Advanced knowledge of Good Clinical Practice and global IVD (or medical device) regulations
It would be a plus if you also possess previous experience in:
Diagnostic product development and IVD technology
Certification as a Clinical Research Associate or a Clinical Research Professional
GLP Standards
At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.The salary range for this role is $110,000 – 140,000. 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. We may ultimately pay more or less than the posted range. 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.#LI-LM1.At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. 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 [email protected] to request accommodation.