New · posted Nov 12
Danaher · Medical Devices
Senior Clinical Study Manager
- Remote, US) - Sunnyvale, CA / Chicago, IL
- Remote
- Full-time
- Manager
The role
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 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 System 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.
What you need
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 innice to have
- 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.
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.
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.
The U.S. EEO posters are available here.
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.
What you'll do
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.
Pay and benefits
$116,000 a year
Employer providedThe 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.
Paid time off
Medical/dental/vision insurance
401(k)
Bonus/incentive pay
Remote work arrangement
Equal opportunity, accessibility and legal noticesDanaher's statements, word for word
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 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].
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 27% below the US median for Clinical Trial Management roles at this level.
This roleEmployer provided
Manager roles in California8 roles publishing pay
Manager roles in the US48 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $116,000 | — | $116,000 |
| California (middle half) | $153,875 | $163,250 | $171,625 |
| All US (middle half) | $140,000 | $159,500 | $169,500 |
This role: Danaher's own published range. Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 85 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not Danaher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct11
- Collaboration and leadership7
- Documentation and SOPs3
- Lab testing and methods2
- Quality systems and risk2
- GMP and compliance1
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Trial Management work in medical devices, each linked to the agency or standards body that publishes it.
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
Company hiring pulse
Danaher on Regulatory Jobs
- 57
- Open roles
- 57
- Distinct roles
- 20
- Locations
By discipline
- Quality47 81%
- Regulatory7 12%
- Clinical4 7%
By level
- Senior & Principal27 47%
- Associate & Specialist20 34%
- Manager9 16%
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Senior Clinical Study Manager at Danaher
Open until filled. $116K a year, employer provided.