Clinical Research, Clinical Safety Manager

We need to output HTML fragment with sections: headings

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We need to parse the posting. Key info: - Job title: Clinical Research, Clinical Safety Manager (but we don't repeat as heading) - Location: remote from home office based in USA within reasonable proximity to a major airport. - Start date: October 16, 2026. - Why Castle Biosciences? bullet list: 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%, 3 Health Care Plan Options + Company HSA Contribution, Company Stock Grant Upon Hire. - A DAY IN THE LIFE OF AN Clinical Safety Manager: description of responsibilities. - Required Qualifications: bullet list of qualifications. - SCHEDULE: Monday-Friday, 40 hours per week. Remote position based in US. Candidates must reside within reasonable proximity to a major airport. Occasional overnight travel up to 10% may be required. - Also mention "Please see the full job description at the end of the job ad." but we ignore. - Also "READY TO JOIN OUR BIOTECH TEAM?" etc is application instruction, remove. - Also "Castle Biosciences Awards and Research Developments!" etc maybe not needed. - Also "WORK AUTHORIZATION" etc: we can include maybe as a short paragraph? It's not a heading but could be included as prose. However we should remove boilerplate like EEO etc. Work authorization is specific: "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." That's substantive, we can include as a paragraph maybe under a generic section? There's no heading for that. Could include as a

after other sections. - Also "About Castle Biosciences Inc." description: we can include as About the role? Actually "About Castle Biosciences Inc." is about company, not role. Could be "About the role" or "About the company". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can map: - About the role: maybe the introductory paragraph about role? The posting includes "Why Castle Biosciences?" and "A DAY IN THE LIFE OF AN Clinical Safety Manager". Could treat "About the role" as summary of role and why join. But we need to avoid filler. Better to create sections: - About the role: short paragraph describing role purpose (maybe from first sentences: "The Clinical Research Safety Manager is responsible for establishing, implementing, and continuously improving clinical research safety processes..."). - Responsibilities: list from that paragraph and maybe the "partners with cross-functional teams..." etc. - Requirements: maybe combine Required Qualifications bullet list. - Qualifications: maybe separate education vs experience? But we can just have one Qualifications section with bullet list. - Benefits: from "Why Castle Biosciences?" bullet list. - Pay: includes "Excellent Annual Salary + 20% Bonus Potential". That's pay info. - Schedule: from SCHEDULE section. We must not create sections with filler like "commensurate with experience". We have actual specifics. We need to preserve all substantive info, not invent or summarize away detail. So we need to include all details from the posting. Let's extract details: **About the role** (maybe we can include a paragraph summarizing role purpose). The posting includes: "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." That's a lot; we can keep as prose in About the role or Responsibilities. Probably better to split: About the role: brief overview; Responsibilities: bullet list of duties. Let's pull bullet list of duties from that paragraph: - Establishing, implementing, and continuously improving clinical research safety processes for LDT and medical device organization. - Ensuring compliance with applicable regulations, Company policies, and SOPs. - Serving as 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 development of safety processes, study documentation, and training. - Providing support as directed by leadership. - Contributing to growth of the clinical research safety function. We can put these as

• . **Requirements** maybe include education and experience: "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." We can split into Requirements (education + years) and Qualifications (specific knowledge/experience). But the instruction says we can have both Requirements and Qualifications sections if they have real content. We'll make: - Requirements: Bachelor's degree ... 5+ years of relevant experience ... - Qualifications: Experience supporting sponsor-led clinical studies ... Working knowledge of FDA ... Experience assessing and documenting adverse events ... But we might duplicate. Safer to combine into one Qualifications section and maybe not have Requirements. However we need to follow instruction: "Prefer a few substantive sections over many thin ones." So maybe combine education+experience into Qualifications. But we also have Benefits, Pay, Schedule. Let's decide sections: - About the role (paragraph) - Responsibilities (ul) - Qualifications (ul) (includes education, experience, specific knowledge) - Benefits (ul) - Pay (p or ul?) Pay: "Excellent Annual Salary + 20% Bonus Potential". Could be a

  . - Schedule (p) includes Monday-Friday, 40 hours per week, remote, proximity to major airport, occasional travel up to 10%. Also we might include a short paragraph for 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." Could be a

  after Schedule or as its own section? There's no heading for that; we could just add a

  after Schedule. Also we have start date: October 16, 2026. Should we include? It's substantive. Could be included in About the role or as a separate paragraph. Maybe include in About the role paragraph: "Start date: October 16, 2026." Also location: remote from home office based in USA within reasonable proximity to a major airport. That's in Schedule. Let's craft. We must not include boilerplate like EEO, equal opportunity, etc. We'll omit those paragraphs. Now produce HTML fragment:

  About the role

  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. Start date: October 16, 2026.

  Responsibilities

  • Establishing, implementing, and continuously improving clinical research safety processes for LDT and medical device organization.
  • Ensuring compliance with applicable regulations, Company policies, and 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.

  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.

  Benefits

  • 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%
  • 3 Health Care Plan Options + Company HSA Contribution
  • Company Stock Grant Upon Hire

  Pay

  Excellent Annual Salary + 20% Bonus Potential

  But note Pay duplicates Benefits item; we might not need separate Pay section if it's already in Benefits. However instruction