Clinical Research, Clinical Safety Manager

Job Description

Job Description

Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood! Learn more at Biosciences Inc. is growing, and we are looking to hire a full-time Clinical Research, Clinical Safety Manager working from our Phoenix, AZ, Friendswood, TX or Pittsburgh, PA office location, with a start date of August 1, 2026.Why Castle Biosciences?Exceptional Benefits Package:Excellent Annual Salary + 20% Bonus Potential20 Accrued PTO Days Annually + 10 Paid Holidays401K with 100% Company Match up to 6%3 Health Care Plan Options + Company HSA ContributionCompany Stock Grant Upon HireA DAY IN THE LIFE OF AN Clinical Safety ManagerThe 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 QUALIFICATIONSBachelor '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.*Please see the full job description at the end of the job ad.SCHEDULEMonday-Friday, 40 hours per week, working from our Phoenix, AZ, Friendswood, TX or Pittsburgh, PA office locations.Occasional overnight travel, up to 10%, may be required to support site engagement, audits/inspections, study meetings, training, or conferences.READY TO JOIN OUR BIOTECH TEAM?We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon!Castle Biosciences Awards and Research Developments!WORK AUTHORIZATIONAll 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 fosters 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. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail [email protected] 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