Senior Clinical Lab Research Specialist (IVD)

MillenniumSoft Inc; Franklin Lakes (NJ); On-site; USD 94,000 - 104,000; Full time

Job summary

MillenniumSoft Inc in Franklin Lakes, NJ seeks a Clinical Laboratory Research Specialist (min 5+ yrs in regulated industry) for a 12-month onsite contract. The role involves design, evaluation, execution and reporting for safety and efficacy of in‑vitro diagnostic devices, and collaboration with R&D and other functions.

Requires BS/BA/MA in Clinical Laboratory Science or Medical Technology; MT/MLT CLS (ASCP); 5+ years in clinical lab.

Qualifications

• BS/BA/MA in Clinical Laboratory Science or Medical Technology is required.
• MT/MLT CLS (ASCP) or equivalent experience in a Research environment.
• 5+ years of experience in the Clinical Laboratory environment.

Responsibilities

• Provide input to design, evaluation, execution and reporting for safety and efficacy of in‑vitro diagnostic devices.
• Manage clinical laboratory studies and complaint testing across various testing methods.
• Develop/implement testing methodologies in collaboration with R&D and cross functional teams.
• Ensure alignment with quality and regulatory standards (GLP/GCP).
• Trains new associates on Laboratory workflow and supports innovation and product development.

Skills

Clinical laboratory science

Regulatory knowledge

Quality systems

GCP/GLP awareness

Communication

Education

BS/BA/MA in Clinical Laboratory Science or Medical Technology

MT/MLT CLS (ASCP)

Job description

MillenniumSoft Inc in Franklin Lakes, NJ seeks a Clinical Laboratory Research Specialist (min 5+ yrs in regulated industry) for a 12-month onsite contract. The role involves design, evaluation, execution and reporting for safety and efficacy of in‑vitro diagnostic devices, and collaboration with R&D and other functions.

Requires BS/BA/MA in Clinical Laboratory Science or Medical Technology; MT/MLT CLS (ASCP); 5+ years in clinical lab.