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Clinical Affairs Manager

1 month ago

Phoenix, Arizona, United States Danaher Corporation Full time

Wondering what is within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you will see that for more than 80 years we have 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 are building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you will 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 are working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

The Clinical Affairs Manager for Beckman Coulter Diagnostics is responsible for directly managing a team of direct reports in the organization and will play a critical role in the timely, effective, and quality completion of a cardiac enrollment clinical study. This position is responsible for systematic and organized clinical operations, metrics and KPIs, financial forecasting and budget reconciliation.

This position is part of the Clinical Chemistry and Immunoassay (CCIA) Clinical Affairs department located in Chaska, Minnesota 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 CCIA Clinical Affairs team and report to the Senior Manager Clinical Affairs who is responsible for managing the CCIA Cardiac-Reagent clinical portfolio. If you thrive in a an amazing, multifunctional, fast paced role and want to work to build a world-class clinical affairs organization—read on.

In this role, you will have the opportunity to:

  • Manage a team of Clinical Research Associates assigned to site management and data review of a new cardiac enrollment study, which involves active mentoring, regular coaching, and developing people to build skills and elevate capabilities.
  • Form strong relationship with key Investigators and coordinators, driving high clinical site engagement (e.g., newsletters, video meetings)
  • Accountable to ensure the team is trained and follows the currently approved protocol/amendment(s), SOPs, GCP, PHI, and applicable regulatory requirements.
  • Drive clinical schedule deliverables and project financial forecasts to meet the overall project timelines, influencing internal and external partners to support on-time-delivery through relationship management skills as well as execute a well-controlled operation to manage sample chain-of-custody and investigational product reconciliation.
  • Drive highly organized, coordinated reviews of metrics and KPI (e.g., cycle times, query age, SDV rate, deviation trending and manage and frequently analyze data to track progress and assign clear actions.

The essential requirements of the job include :

  • Bachelor's Degree in field with 9+ years of experience in Medical Device, In-Vitro Diagnostic, or a related field, 7+ years of experience with Master's Degree, or 4+ years of experience with a PhD degree.
  • Minimum of 2 years of directly leading a team and managing people.
  • Knowledge and experience with GCP and global medical device / IVD regulations.
  • Operational excellence mindset, detailed-oriented, critical thinker, problem-solver.
  • Able to travel for business 25-35%.

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

  • Leading a complex multicenter enrollment study with direct FDA submission or interaction
  • Technical or medical knowledge of cardiac or heart failure disease
  • Experience partnering with Data Management to build eCRF, EDC, and study management reports and actively participated in either internal or external study audits

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 $120,000 to $150,000 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.

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

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 ) .

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 to request accommodation.


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