Senior Clinical Study Manager

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business Syste m which makes everything possible.

The Senior Clinical Program Manager is responsible for managing the overall clinical execution of pre-clinical and clinical trials across a program including project planning, budget, resource management and, if required, contract research organization management (CRO).  The Senior CSM also provides oversight, supervision, and mentorship to associates assigned to their project.

This position reports to the Senior Director, Clinical Programs and is part of the Clinical Development team located in Sunnyvale, CA and will be fully remote.

In this role, you will have the opportunity to:

• Lead end-to-end clinical trial execution, from planning, site selection, qualification, start-up, and training through enrollment, monitoring, and closeout, including specimen and study-material readiness and accountability.

• Oversee clinical staff and coordinate sites, CROs, vendors, and external laboratories to execute study plans, standardize workflows, and drive continuous improvement.

• Develop and maintain study documentation and oversight records to ensure protocol compliance, traceability, inspection readiness, and effective risk and issue management.

• Manage clinical trial budgets, resources, timelines, and milestones; track performance against plans and recommend adjustments as needed.

• Partner with executive leadership and cross-functional teams, including R&D, Medical/Scientific Affairs, Regulatory, Quality, Finance, Data Management, Clinical Science, and Biostatistics, to coordinate data review, study completion, decisions, and progress reporting.

The essential requirements of the job include:

• Bachelor’s degree in a scientific discipline or equivalent experience

• 8+ years of clinical research experience in the medical device (IVD preferred), biotechnology, or pharmaceutical industries

• Working knowledge of FDA regulatory requirements related to clinical research

Travel Requirements:

• Up to 20% travel

It would be a plus if you also possess previous experience in:

• At least 3 years of clinical research associate (CRA) experience and 3 years of study management experience

• Experience with in vitro diagnostic clinical trials

• Experience with clinical trials in infectious diseases and/or oncology

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 Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

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 annual salary range for this role is $116,000 – 170,000. 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.#LI-DN1

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.

The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc) .

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [email protected].

Operating Company: Cepheid