Employment Type : Full-Time
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 Manager 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 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.
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 or equivalent experience
5 to 7 years of clinical research 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
Sunnyvale based associate: US (international possible) travel requirements up to 20% in non-pandemic times
Remotely based associate: up to 40% travel to Sunnyvale up to 20% in non-pandemic times
other US (some international) travel up to 20% in non-pandemic times
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 .
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 tools and the stability of a tested organization.
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.
If you’ve ever wondered what’s within you, there’s no better time to find out.
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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 tools and the stability of a tested organization.