Clinical Research, Clinical Safety Manager

Clinical Research, Clinical Safety Manager Castle Biosciences Inc. is growing, and we are looking to hire a full‑time Clinical Research, Clinical Safety Manager based at one of our Phoenix, AZ, Friendswood, TX, or Pittsburgh, PA offices, with a start date of August 1, 2026. 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% Three health‑care plan options + company HSA contribution Company stock grant upon hire Job Overview 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. The 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. Responsibilities The Clinical Safety Manager will: Develop and maintain safety policies, procedures, and documentation for clinical trials. Lead safety planning and risk assessments for all ongoing studies. Manage adverse event reporting, serious adverse event documentation, and safety signal detection. Coordinate with Institutional Review Boards (IRBs)/Ethics Committees and regulatory agencies. Ensure compliance with 21 CFR Parts 803, 812, and 820 and related safety/reporting expectations. Prepare and maintain FDA regulatory submissions, including INDs, IDEs, and pre‑market notifications. Provide training to investigators, study coordinators, and internal teams on safety procedures. Support inspection readiness and post‑market surveillance activities. Act as a safety subject matter expert for cross‑functional projects and initiatives. Required Qualifications Bachelor’s degree in life sciences, nursing, clinical research, biomedical sciences, regulatory/quality, public health, or related field. Five or more years of experience in clinical research, clinical safety, medical device/IVD, diagnostics, regulatory, or quality 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. Experience evaluating and documenting adverse events, serious adverse events, unanticipated problems, unanticipated adverse device effects, protocol‑defined events, deviations, and safety issues. Schedule Monday‑Friday, 40 hours per week. Occasional overnight travel, up to 10%, may be required to support site engagement, audits/inspections, study meetings, training, or conferences. Work Authorization 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. Equal Opportunity & Disability Accommodation Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities. If you have a disability and you believe you need a reasonable accommodation to search for a job opening or to submit an online application, please email View email address on click.appcast.io. #J-18808-Ljbffr Council of State and Territorial Epidemiologists