Clinical Research, Clinical Safety Manager

Castle Biosciences•,

56d•Remote

About The Position

Castle Biosciences is hiring a full-time Clinical Safety Manager to work remotely from a home office in the United States, within reasonable proximity to a major airport. The stated start date is October 16, 2026. This individual contributor is the operational safety lead for company-sponsored clinical studies at a laboratory-developed test (LDT) and medical device organization. The role establishes, implements, and continually improves clinical research safety processes while ensuring compliance with applicable regulations, company policies, and standard operating procedures. The manager oversees safety planning, adverse event management, risk assessments, safety reporting, and regulatory documentation for FDA-regulated LDT, IVD, and medical device studies. The role partners with cross-functional teams to support participant safety, regulatory compliance, inspection readiness, and alignment between clinical safety activities, quality systems, and post-market processes. It also supports the development of safety processes, study documentation, and training, and contributes to the growth of the clinical research safety function. The schedule is Monday through Friday, 40 hours per week. Occasional overnight travel of up to 10% may be required for site engagement, audits or inspections, study meetings, training, or conferences. Candidates must be legally authorized to work in the United States; the company does not sponsor H-1B, OPT, or employment-related visas.

Requirements

Bachelor's degree in life sciences, nursing, clinical research, public health, regulatory affairs, quality assurance, or a related field.
At least 5 years of relevant experience in clinical research, medical devices or diagnostics (including IVDs/LDTs), regulatory affairs, quality, or a related discipline in a regulated healthcare environment, with responsibilities related to clinical safety management.
Experience supporting sponsor-led clinical studies, including protocol review, safety-reporting processes, IRB/ethics committee interactions, and study documentation.
Working knowledge of applicable FDA clinical research, medical device, and safety-reporting requirements, including 21 CFR Parts 50, 56, 803, and 812, and Part 820, the Quality Management System Regulation (QMSR).
Experience assessing and documenting adverse events, including serious adverse events, unanticipated problems, unanticipated adverse device effects, protocol-defined events, protocol deviations, and other safety concerns.
Legally authorized to work in the United States.
Must reside within reasonable proximity to a major airport.

Responsibilities

Establish, implement, and continuously improve clinical research safety processes.
Serve as the operational safety lead for company-sponsored clinical studies.
Oversee safety planning, adverse event management, risk assessments, safety reporting, and regulatory documentation for FDA-regulated LDT, IVD, and medical device studies.
Partner with cross-functional teams to support participant safety, regulatory compliance, and inspection readiness.
Align clinical safety activities with quality systems and post-market processes.
Support the development of safety processes, study documentation, and training.
Contribute to the growth of the clinical research safety function.
Provide support as directed by leadership.