Study Director I: Lab Study Lead & Compliance Expert

Nelson Laboratories, LLC; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Sotera Health seeks a Study Director to lead the technical conduct of assigned tests and to review, interpret, and report results. This role serves as the single point of study control, ensuring studies are completed on time and in compliance with GMP, GLP, and ISO standards.

Responsibilities include maintaining data traceability, approving reports, and collaborating with QA, QE, and Sales. A life sciences degree and Study Director Training are required, with relevant NL laboratory experience

Qualifications

• B.S. degree (life science strongly preferred) or A.A./A.S. or equivalent with two years NL laboratory experience, or High School diploma or GED with five years NL laboratory experience.
• Successful completion of Study Director Training.
• Experience coordinating studies and ensuring tests follow procedures and regulatory requirements.

Responsibilities

• Oversee the technical conduct of all assigned tests and ensure timely completion.
• Review, interpret, analyze, and report results with final signature on reports.
• Ensure reports comply with procedures and data reflect raw data accurately.
• Maintain data traceability and participate in QA and QE processes.
• Communicate study updates and CSS details to sponsors; collaborate with Sales on testing quotes.

Skills

Lab oversight

GDP

Regulatory knowledge

Critical thinking

Communication

Attention to detail

Study Director Training

Data interpretation

Documentation

Education

B.S. degree (life science preferred)

A.A./A.S. or equivalent

High School diploma or GED

Tools

Laboratory systems

Microsoft Office

Job description

Sotera Health seeks a Study Director to lead the technical conduct of assigned tests and to review, interpret, and report results. This role serves as the single point of study control, ensuring studies are completed on time and in compliance with GMP, GLP, and ISO standards.

Responsibilities include maintaining data traceability, approving reports, and collaborating with QA, QE, and Sales. A life sciences degree and Study Director Training are required, with relevant NL laboratory experience