Remote Clinical Research & Safety Lead

Texas Health Institute; Phoenix, Northern (AZ, KY); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

20 Accrued PTO Days Annually + 10 Paid

5 Health Care Plan Options + Company H

Company Stock Grant Upon Hire

401K with company match

Job summary

Castle Biosciences Inc. is seeking a Clinical Research, Clinical Safety Manager to join our remote team from a home office in the USA, near a major airport, with a start date of October 16, 2026.

You will establish, implement, and improve clinical safety processes for LDTs and medical devices, ensuring FDA/regulatory compliance and alignment with QA and post-market activities. You will lead safety planning, adverse event management, risk assessments, safety reporting, and regulatory

Qualifications

• Bachelor's degree in life sciences or related field.
• 5+ years in clinical research, medical devices, or regulated healthcare.
• Experience with sponsor-led studies and safety reporting processes.
• Knowledge of FDA requirements for clinical research and QMSR.

Responsibilities

• Establish and improve clinical safety processes for LDTs and medical devices.
• Lead adverse event management, risk assessments, and safety reporting.
• Prepare regulatory documentation for FDA-regulated studies.
• Collaborate with cross-functional teams to ensure participant safety and compliance.

Skills

Clinical research

Medical devices

Regulatory affairs

Safety reporting

AE assessment

Education

Bachelor's degree

Job description

Castle Biosciences Inc. is seeking a Clinical Research, Clinical Safety Manager to join our remote team from a home office in the USA, near a major airport, with a start date of October 16, 2026.

You will establish, implement, and improve clinical safety processes for LDTs and medical devices, ensuring FDA/regulatory compliance and alignment with QA and post-market activities. You will lead safety planning, adverse event management, risk assessments, safety reporting, and regulatory