Clinical Research, Clinical Safety Manager

Sacbar; Phoenix, Northern (AZ, KY); Hybrid; USD 120,000 - 165,000; Full time

Benefits offered by this job

Excellent salary + 20% bonus potential

PTO + holidays

401K with company match

Health plan options + company HSA

Stock grant on hire

Job summary

Castle Biosciences Inc. is seeking a full-time Clinical Research, Clinical Safety Manager to work remotely from a home office in the USA near a major airport, with a start date of October 16, 2026.

The role requires establishing and managing safety processes for LDT and medical device studies, ensuring regulatory compliance and collaboration with cross-functional teams. The ideal candidate has 5+ years in clinical research or regulatory affairs, deep knowledge of FDA requirements, and experience

Qualifications

• Bachelor's degree in life sciences, nursing, clinical research, public health, regulatory affairs, quality assurance, or a related field.
• 5+ years of clinical research, medical devices/diagnostics, regulatory affairs or related safety management experience.
• Experience supporting sponsor-led clinical studies with protocol review and safety reporting.
• Familiarity with FDA requirements including 21 CFR Parts 50, 56, 803, 812, and Part 820.
• Ability to document adverse events including SAEs and unanticipated events.

Responsibilities

• Establish and continuously improve clinical research safety processes for LDT and medical devices.
• Oversee safety planning, adverse event management, risk assessments and safety reporting.
• Manage regulatory documentation for FDA-regulated studies and ensure SOP alignment.
• Collaborate with cross-functional teams to ensure participant safety and inspection readiness.
• Develop safety process documentation and training, supporting leadership as needed.

Skills

Clinical research

Regulatory affairs

Adverse event management

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in life sciences or related field

Job description

• Clinical Research, Clinical Safety Manager

Castle Biosciences Inc. is growing, and we are looking to hire a full-time Clinical Research, Clinical Safety Manager working remotely from your home office based in the USA within reasonable proximity to a major airport, with a start date of October 16, 2026.

Why Castle Biosciences?

Exceptional Benefits Package:

• Excellent Annual Salary + 20% Bonus Potential
• 20 Accrued PTO Days Annually + 10 Paid Holidays
• 401K with 100% Company Match up to 6%
• 3 Health Care Plan Options + Company HSA Contribution
• Company Stock Grant Upon Hire

A DAY IN THE LIFE OF AN Clinical Safety Manager

The Clinical Research Safety Manager is responsible for establishing, implementing, and continuously improving clinical research safety processes for a laboratory-developed test (LDT) and medical device organization while ensuring compliance with applicable regulations, Company policies, and Standard Operating Procedures (SOPs). This role serves as the operational safety lead for company-sponsored clinical studies, overseeing safety planning, adverse event management, risk assessments, safety reporting, and regulatory documentation for FDA-regulated LDT, IVD, and medical device studies. The position partners with cross-functional teams to ensure participant safety, regulatory compliance, inspection readiness, and alignment between clinical safety activities, quality systems, and post-market processes. This individual contributor role also supports the development of safety processes, study documentation, and training while providing support as directed by leadership and contributing to the growth of the clinical research safety function.

REQUIRED QUALIFICATIONS

• Bachelor's degree in life sciences, nursing, clinical research, public health, regulatory affairs, quality assurance, or a related field.
• 5+ years of relevant experience in clinical research, medical devices or diagnostics (including IVDs/LDTs), regulatory affairs, quality, or a related discipline within 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, as well as 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.

Please see the full job description at the end of the job ad.

SCHEDULE

• Monday-Friday, 40 hours per week. This is a remote position based in the United States. Candidates must reside within reasonable proximity to a major airport.
• Occasional overnight travel, up to 10%, may be required to support site engagement, audits/inspections, study meetings, training, or conferences.

All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.

ABOUT CASTLE BIOSCIENCES INC.

At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes.

Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture foster an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development.

Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.

No third-party recruiters, please

ABOUT CASTLE BIOSCIENCES INC.Castle Biosciences is improving health through our innovative tests that guide patient care. For the diseases that our portfolio of tests covers, we believe the traditional approach to developing a treatment plan for cancers and other diseases using clinical and pathology factors alone is inadequate and can be improved by incorporating the personalized information our tests provide. Our innovative tests for skin cancers, uveal melanoma, and Barrett's esophagus provide personalized, clinicall...