Clinical Operations Program Manager - Chicago, Sunnyvale CA or REMOTE

Company: Cepheid
Location: New Haven
Posted on: November 24, 2022

Job Description:

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 which makes everything possible. The Clinical Operations Project Managerwill 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 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 Oncology diagnostics products in our dynamic organization-read on. This position is part of Clinical Operations and will be located remote. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions. In this role, you will have the opportunity to:

• Manages clinical operational plan, and incorporates the study and scientific plan
• Manages clinical budget and develops contingency plans for clinical trials
• Oversees Operations staff, both regular and contract staff, and manages all aspects of clinical operational plan
• Responsible for managing full operational scope of study
• Partner with clinical research lead to serve as clinical affairs representatives on new product development core teams The essential requirements of the job include:
  • Bachelor's degree in a scientific discipline with 5+ yrs of related work experience OR Master's degree in field with 3+ years related work experience OR doctoral degree in field with 0-2+ years related work experience
  • Clinical research and operations experience within medical device (IVD preferred), biotech, or pharmaceutical
  • Clinical operations experience
  • Working knowledge of FDA and/or CE-IVD and GCP regulatory requirements related to clinical studies
  • Ability to travel 20 - 40% to Sunnyvale, CA; Solna, Sweden and other locations as needed. It would be a plus if you also possess previous experience in:
    • At least 3 years of CRA experience and 1 years of study management experience
    • Experience with in vitro diagnostic clinical trials
    • Experience working with infectious diseases 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. At Cepheid 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 Cepheid can provide. The salary range for this role is $120,000 - 138,000 base pay annually. 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 is only applicable for jobs to be performed in Colorado. 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. #LI-REMOTE #LI-JW1 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 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.
      
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Keywords: Cepheid, New Haven , Clinical Operations Program Manager - Chicago, Sunnyvale CA or REMOTE, Executive , New Haven, Connecticut