Study Director

Responsibilities

• Act as the single point of study control, overseeing the technical conduct, review, and interpretation of assigned laboratory tests.
• Ensure all final reports are compliant with current procedures and accurately reflect data, results, and conclusions.
• Maintain sample and data traceability throughout the testing process and ensure the accuracy of raw data and calculations.
• Follow applicable regulatory requirements including GMP, GLP, and ISO standards.
• Collaborate with customers and the sales department to provide study updates, technical quotes, and meet sponsor expectations.
• Coordinate workflow and manage project timelines to ensure studies are completed on time.
• Oversee analysts to ensure they understand and correctly perform testing on behalf of the study.

Requirements

• B.S. degree in life science strongly preferred (or equivalent experience as specified in the job description).
• Knowledge of laboratory testing, equipment, and procedures.
• Proficiency in Good Documentation Practice (GDP).
• Strong critical thinking, problem-solving, and decision-making skills.
• Proficiency with Microsoft Office and laboratory information systems.
• Ability to follow written procedures and maintain high attention to detail.
• Ability to work in a professional laboratory environment, including wearing required personal protective equipment (PPE).

About the Company

Nelson Labs, part of Sotera Health, is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Driven by the mission of Safeguarding Global Health®, we provide mission-critical services to ensure the safety of millions of patients and healthcare practitioners worldwide.