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Danaher Corporation Clinical Project Manager in New York, New York

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.

In Clinical Affairs we are looking for a passionate Clinical Study Project Manager to join our growing, ambitious team focused on supporting top projects in Beckman Coulter’s largest business – Beckman Coulter’s Chemistry and Immunoassay business. Reporting to the Director of Clinical Affairs, 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 and will be a fully remote role.

This role provides an opportunity to combine your expertise in clinical research and our proprietary work processes to drive continuous process improvement and develop clinical team members. At Beckman Coulter, we Help Realize Life’s Potential by delivering the best diagnostic products to the laboratories, clinicians and patients who need them!

In this role, you will have the opportunity to:

  • Represent the Clinical function in collaboration with a cross-functional project core team to develop and execute:

  • Product Evidence Strategy plan

  • Global Clinical plan

  • Successfully negotiate with government regulatory agencies such as FDA

  • Lead a clinical project team consisting of clinical operations, biostatistics, and data management specialists to complete key clinical outputs, such as:

  • Study protocols and Monitoring plans

  • Data management plan and electronic Case Report Forms

  • Statistical analysis plans and qualifying study investigators

  • Negotiating study contracts and budgets

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

  • Produce compliant, high-quality study data and final study reports

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

  • Provide 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

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

  • Able to travel 10-15% (as travel resumes after current highly restricted corporate guidelines)

Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.

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. If you’ve ever wondered what’s within you, there’s no better time to find out.