Clinical Research, Clinical Safety Manager

Castle Biosciences•Phoenix, AZ

1d•Hybrid

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, biomedical sciences, regulatory/quality, public health, or related field.
5+ years of clinical research, clinical safety, medical device/IVD, diagnostics, regulatory, quality, or related experience in a regulated healthcare environment.
Demonstrated experience supporting sponsor-led clinical studies, preferably device/IVD/LDT studies, including protocol review, safety reporting pathways, IRB/EC interactions, and study documentation.
Working knowledge of FDA clinical research and medical device requirements, including 21 CFR Parts 803, 812, and 820 and applicable safety/reporting expectations.
Experience evaluating and documenting adverse events, serious adverse events, unanticipated problems, unanticipated adverse device effects, protocol-defined events, deviations, and safety issues.

Responsibilities

Establishing, implementing, and continuously improving clinical research safety processes for a laboratory-developed test (LDT) and medical device organization.
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.