Senior Clinical Study Manager
Danaher Corporation
Summary
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.
Job description
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
Requirements
- 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
- Up to 20% travel
- At least 3 years of clinical research associate (CRA) experience and 3 years of study management experience (preferred)
- Experience with in vitro diagnostic clinical trials (preferred)
- Experience with clinical trials in infectious diseases and/or oncology (preferred)
Benefits
- Paid Time Off
- Medical Insurance
- Dental Insurance
- Vision Insurance
- 401(k)
- Bonus/Incentive Pay
- Remote Work
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.