Remote Clinical Safety & Research Manager

ISHE; Phoenix, Northern (AZ, KY); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Excellent annual salary + 20% bonus潜t

20 accrued PTO days annually + 10 paid

401K with 100% Company Match up to 6%

3 Health Care Plan Options + Company H

Company Stock Grant Upon Hire

Job summary

Castle Biosciences Inc. is seeking a full-time Clinical Research, Clinical Safety Manager to work remotely from a home office in the USA, near a major airport.

The role involves establishing and improving clinical safety processes for LDTs, IVDs, and devices, while ensuring regulatory compliance. Responsibilities include safety planning, adverse event management, and regulatory documentation, with cross-functional collaboration to ensure participant safety and inspection readiness.

Qualifications

• Bachelor's degree in life sciences or related field required.
• 5+ years in clinical research, medical devices, or diagnostics in regulated healthcare.
• Experience with safety reporting, IRB interactions, and regulatory submissions.

Responsibilities

• Establish and improve clinical safety processes for LDT, IVD, and devices.
• Lead safety planning, adverse event management, and safety reporting for studies.
• Coordinate with cross-functional teams to ensure participant safety and compliance.
• Maintain regulatory documentation and inspection readiness.

Skills

Clinical safety management

Regulatory compliance

Adverse event assessment

IRB/ethics interactions

Risk assessment

Education

Bachelor's degree in life sciences or related field

Job description

Castle Biosciences Inc. is seeking a full-time Clinical Research, Clinical Safety Manager to work remotely from a home office in the USA, near a major airport.

The role involves establishing and improving clinical safety processes for LDTs, IVDs, and devices, while ensuring regulatory compliance. Responsibilities include safety planning, adverse event management, and regulatory documentation, with cross-functional collaboration to ensure participant safety and inspection readiness.