Clinical Program Manager
Danaher Corporation
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 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 Remote.In this role, you will have the opportunity to:
+ Lead and manage complex programs and oversee Operations staff, both regular and contract staff, and 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 with 8+ years of related work experience or Master’s degree in a scientific discipline with 6+ years of related work experience
+ 5+ years of clinical research experience within medical device (IVD preferred), biotech, or pharmaceutical
+ Working knowledge of FDA regulatory requirements related to clinical research
+ Strong oral and written communication skills; strong technical writing skills
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Travel requirements up to 20%
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 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 $114,700 - 157,700. 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. 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.
Join our winning team today. Together, we’ll 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.
For more information, visit www.danaher.com .
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.
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