Manager, Clinical Operations

2 weeks ago

Solna, Sweden Cepheid 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 Manager for Clinical Operations is responsible for overseeing Clinical Operations staff and manage all aspects of clinical operational plan, managing clinical budget and develop contingency plans for clinical trials. The Manager for Clinical Operations will be involved in department level initiatives, templates, plans, and processes. 

This position is part of the Clinical Operations Organization and will be located in Solna, Stockholm, Sweden. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.



In this role, you will have the opportunity to:

Oversee Clinical Operations staff and manage all aspects of clinical operational plan.

Manage clinical budget and develop contingency plans for clinical trials 

Be involved in department level initiatives, templates, plans, and processes.

Effectivelycommunicate cross functionally (including but not limitedto Executive, R&D, Medical Affairs, Regulatory, Finance and Commercial teams) study updates, timelines, milestones, escalations,budget, andall pertinent study related topics. 

Directly manageof clinical research associates

The essential requirements of the job include:

Bachelor’s degree in a scientific discipline or equivalent experience

5 + years of clinical research experience within medical device (IVD preferred), biotech, or pharmaceutical

Direct People Management experience

Working knowledge of IVDR and FDA regulatory requirements related to clinical studies

Strong oral and written communication skills

Travel requirements up to 20%

It would be a plus if you also possessprevious experience in:

At least 3 years of CRA experience and 1 year of study management experience

Experience with in vitro diagnostic clinical trials 

Experience working with infectious disease clinical trials

Cepheid, a Danaher operating 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 Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, 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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