[Hiring] Clinical Research Safety Manager @Castle Biosciences

Role Description

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
• 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
• 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.

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

Requirements

• 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

Benefits

• 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

Company Description

At Castle, it all comes down 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
• 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 fosters an environment of trust, transparency, and collaboration
• We prioritize and encourage internal growth and professional development