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Danaher Corporation Manager, Clinical Operations (Remote) in Dallas, Texas

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Manager, Clinical Operations will manage the overall operation of pre-clinical and clinical trials including project planning, budget, resource management and, if required, contract research organization management (CRO). Provides direct oversight, supervision, and mentorship to Clinical Operations staff.

If you thrive as a self-driven, independent, focused contributor in a multifunctional, fast paced, innovative role and want to work to build world-class diagnostics products in our dynamic organization—read on.

In this role, you will have the opportunity to:

  • Manage clinical operational plan, and incorporates the study and scientific plan

  • Manage clinical budget and develops contingency plans for clinical trials

  • Oversee Operations staff, both regular and contract staff, and manage all aspects of clinical operational plan

  • Manage the full operational scope of study

  • Partner with the Clinical Research lead to serve as the clinical affairs representatives on new product development core teams

  • Manage Clinical Research Associates and other clinical operations staff

    The essential requirements of the job include:

  • Bachelor’s degree in a scientific discipline with 9+ years of clinical research experience within medical device (in vitro diagnostic preferred), biotech, or pharmaceutical

  • Minimum of 1 year experience managing clinical research associates and/or clinical operations projects

  • Working knowledge of FDA and/or CE-IVDR and GCP regulatory requirements related to clinical studies

  • Travel:

  • Sunnyvale based associate: US travel requirements up to 20% in non-pandemic times

  • Chicago and Remote based associate: Sunnyvale travel requirements up to 40% in non-pandemic times; US travel requirements up to 20% in non-pandemic times

  • International travel up to 20%

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

  • 2+ years of people management experience

  • Experience with in vitro diagnostic clinical trials

Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our 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 .

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When you join us, you’ll also be joining Danaher’s global organization, where 80,000 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 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.

Operating Company: Cepheid

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