Senior Clinical Study Manager

Danaher•Chicago, IL

2d•Remote

About The Position

Cepheid is hiring a Senior Clinical Study Manager to manage clinical execution across a program, including pre-clinical and clinical trials. The role covers study planning, budgets, resources, and, when required, CRO management. It also provides oversight, supervision, and mentorship to associates assigned to projects. The position reports to the Senior Director, Clinical Programs, and is part of the Clinical Development team. It is based in Sunnyvale, California, and is eligible for fully remote work from home. Travel of up to 20% is required. The role leads clinical trial execution from planning and site selection through study closeout; oversees clinical staff and external partners; maintains study documentation and oversight records; manages budgets, resources, timelines, and milestones; and partners with executive leadership and cross-functional teams on data review, study decisions, completion, and progress reporting. The annual salary range is $116,000–$170,000, with eligibility for bonus or incentive pay.

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.
Working knowledge of FDA regulatory requirements related to clinical research.
Willingness to travel up to 20%.

Nice To Haves

Medical device clinical research experience, preferably in in vitro diagnostics (IVD).
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, and closeout.
Ensure 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 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.
Manage CROs when required.