Clinical Program Manager

Danaher

Solna, Stockholm
Permanent
Heltid

1 månad sedan

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 which makes everything possible.The Clinical Program Manager is responsible for managing 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.This position is part of the Clinical Affairs department and will be located in Solna, Stockholm, Sweden.In this role, you will have the opportunity to:

Oversee Operations staff, both regular and contract staff, and manages all aspects of clinical operational plan.
Develop study related documents and overall direction for the clinical sites to establish protocol development.
Manage clinical budget and develops contingency plans for clinical trials
Responsible for managing full scope of study.
Develop and maintain effective communication across functions, including the Executive, R&D, Medical Affairs, Regulatory, Finance and Commercial teams; including regular reporting on adherence to timelines, milestones and budget, with recommendations for plan adjustments as needed.

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
Working knowledge of FDA and/or IVDR regulatory requirements related to clinical research
Strong oral and written communication skills in English; strong technical writing skills
Ability to travel occasionally a few times per year

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 and/or oncology 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 .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.

Danaher

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