Clinical Affairs Scientific Study Manager

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.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 Clinical Affairs Scientific Study Manager for Beckman Coulter Diagnostics is responsible for Managing the In-Vitro Diagnostic Clinical Research for the Neurodegenerative Disease Portfolio.This position is part of the Clinical Affairs Department located in Chaska, MN and remote. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.You will be a part of the Clinical Affairs Team and report to the Senior Manager of Clinical Affairs responsible for In-Vitro Diagnostic Clinical Research. If you thrive in an innovative, dynamic role and want to work to build a world-class Clinical organization—read on.In this role, you will have the opportunity to:

Design and lead early phase clinical research focused on neurodegenerative disease clinical evidence planning and portfolio development.

Develop clinical strategy, protocol design, case report form and informed consent design.

Manage clinical study timelines, resource demand and budget across the disease portfolio.

Develop internal and external partnerships to ensure stakeholder satisfaction.

Support good clinical practice and scientific integrity concepts.

Proactively identify and resolve business challenges and/or regulatory issues.

The essential requirements of the job include:

Bachelor’s Degree in field with 14+ years of experience or a master’s degree with 12+ years of experience or PhD/MD degree with 9+ years of experience

Experience designing sponsored clinical studies for in vitro diagnostic (IVD), pharmaceutical, or medical device.

Advanced knowledge of Good Clinical Practice and global IVD medical device

Experience developing regulatory strategy as it relates to clinical study design and negotiating with regulatory agencies as a subject matter expert.

Experience in neurodegenerative disease clinical research

It would be a plus if you also possess previous experience in:

Experience working with external strategic partners.

Experience collecting real world evidence.

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 annual salary range for this role is $150 - $200 K. 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.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 applyassistance@danaher.com to request accommodation.