Senior Clinical Study Manager
About The Position
Cepheid, a Danaher operating company, develops molecular diagnostic systems and tests to improve healthcare. The Senior Clinical Study Manager is responsible for managing overall clinical execution of pre-clinical and clinical trials across a program, including project planning, budgets, resource management, and, when required, contract research organization management. The role also provides oversight, supervision, and mentorship to associates assigned to projects. This position is part of the Clinical Development team, reports to the Senior Director, Clinical Programs, and is based in Sunnyvale, California. It is eligible for a fully remote work arrangement. Travel of up to 20% is required.
Requirements
- Bachelor’s degree in a scientific discipline or equivalent experience.
- At least 8 years of clinical research experience in the medical device, biotechnology, or pharmaceutical industries; medical device experience, preferably IVD, is specified.
- Working knowledge of FDA regulatory requirements related to clinical research.
- Up to 20% travel.
Nice To Haves
- 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.
Responsibilities
- Lead end-to-end clinical trial execution, including planning, site selection and qualification, start-up, training, enrollment, monitoring, closeout, and readiness and accountability for specimens and study materials.
- 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 support 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.
- Provide oversight, supervision, and mentorship to associates assigned to projects.
Benefits
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Bonus/incentive pay
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What This Job Offers
Job Type
Full-time
Career Level
Senior
