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Danaher Corporation Clinical Study Project Manager in Englewood, Colorado

Wondering what’s within Beckman Coulter?

Take a closer look.

Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and see we are invested in you and you’ll have the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. Find the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) , which makes everything possible. We are a company that investors trust—our culture of continuous improvement has helped us outperform the S&P 500 by more than 5,000% over the past 25 years.

The heart of what we do is our shared purpose—helping realize life’s potential—in action. Our work helps improve millions of lives.

We hope you’ll see yourself here, too.

What you find at Beckman Coulter —and within yourself — might just change the world!

In the Clinical Study Project Manager (Staff Clinical Scientist) position for Beckman Coulter Diagnostics, we provide an opportunity to combine your expertise in clinical research and our proprietary work processes to drive continuous process improvement and develop clinical team members.

This position can be based remotely or in the Chaska, MN area. Travel is currently highly restricted due to corporate pandemic guidelines, but the ability to travel up to 35% is critical. This role is integral to the business in maintaining and expanding the product portfolio by generation of clinical evidence to support product registration, post-market reporting, and marketing strategy.

This role reports to the Head of Clinical Affairs while working on a cross-functional project core team to develop and execute the Product Evidence Strategy plan, a Global Clinical plan and successfully negotiate with government regulatory agencies such as the FDA.

This is the opportunity to lead a clinical project team of clinical operations, biostatistics and data management specialists to complete key clinical outputs such as

  • Study protocols, monitoring plans statistical analysis plan and data management plan and electronic Case Report Forms

  • Qualifying study investigators

  • Negotiating study contracts and budgets

  • Performing clinical study monitoring activities consistent with Good Clinical Practice standards

  • Compliant, high-quality study data and final study reports

  • Facilitating publication of clinical data in professional journals and company literature

  • Providing work direction and mentorship to developing Clinical Research Associates

The essential requirements of the job include:

  • Bachelor’s degree with 9+ years’ relevant clinical studies experience, Master’s with 7+ years’ experience, or Doctoral degree with 4+ years

  • Experience crafting, organizing, and conducting complex multicenter global clinical trials for Medical Devices or deep technical knowledge of In-Vitro Diagnostic product development with direct experience in characterization, verification or clinical validation testing at external sites

  • Experience reviewing and summarizing clinical data analyses for study reports and publication

This experience is a plus:

  • Other device or pharmaceutical experience in cardiac, hepatic, thyroid, reproductive disease

Beckman Coulter, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to associates’ and their families’ lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

At Beckman Coulter, we’re driven by a sense of wonder for what we can create—and what we can become. As part of the Danaher family of 67,000 associates across the globe, the possibilities for growth and development are unparalleled.

We believe that creativity and innovation thrive when the most diverse set of voices are heard, and that’s why we’re taking concrete steps to ensure that we’re fostering an inclusive and engaging workplace for our team. To learn more, read stories from our associates on our Careers Blog (https://jobs.danaher.com/global/en/blog) or contact one of our recruiters.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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