Clinical Research, Clinical Safety Manager

Castle Biosciences•,

6d•Remote

About The Position

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.

Requirements

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.

Responsibilities

Establishing, implementing, and continuously improving clinical research safety processes.
Ensuring compliance with applicable regulations, Company policies, and Standard Operating Procedures (SOPs).
Serving 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.
Partnering with cross-functional teams to ensure participant safety, regulatory compliance, inspection readiness, and alignment between clinical safety activities, quality systems, and post-market processes.
Supporting the development of safety processes, study documentation, and training.
Providing support as directed by leadership.
Contributing to the growth of the clinical research safety function.