Clinical Research Safety Manager - 119425

Medix™; Phoenix (AZ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Job summary

Medix seeks a Clinical Safety Manager to establish and continuously improve clinical safety processes for LDT and medical device studies in a regulated healthcare environment. You will lead safety planning, adverse event management, risk assessments, and safety reporting, ensuring regulatory compliance.

You will partner with cross-functional teams to align clinical safety activities with quality systems, post-market processes, and leadership direction, contributing to program growth and audit

Qualifications

• 5+ years in clinical research safety or regulated healthcare settings.
• Experience supporting sponsor-led device/IVD/LDT studies and safety reporting.
• Knowledge of FDA clinical research and medical device requirements (21 CFR parts 803/812/820).
• Experience documenting adverse events and safety issues.
• Ability to collaborate with cross-functional teams and regulatory bodies.

Responsibilities

• Establish, implement, and continuously improve clinical research safety processes for LDT/medical device studies.
• Oversee safety planning, adverse event management, risk assessments, and safety reporting.
• Maintain regulatory documentation and ensure inspection readiness.
• Collaborate with cross-functional teams to align safety with quality systems and post-market processes.

Skills

Clinical safety experience

Adverse event assessment

Regulatory compliance

IRB/EC interactions

Education

Bachelor's degree in life sciences or related field

Tools

FDA regulations knowledge (21 CFR Parts 803/812/820)

Job description

A DAY IN THE LIFE OF AN Clinical Safety Manager 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.

REQUIRED QUALIFICATIONS

• Bachelor'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.

SCHEDULE

• Monday-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.