Study Director

Responsibilities

• Hold overall responsibility for the technical conduct of assigned tests, including review, interpretation, and reporting of results.
• Act as the single point of study control to ensure all assigned studies are completed on time and comply with current procedures.
• Ensure sample and data traceability, accuracy of raw data, and correct application of calculations and statistics.
• Maintain regulatory compliance by following GMP, GLP, and ISO requirements and company policies.
• Collaborate with customers and the sales department to provide study updates, testing quotes, and meet sponsor expectations.
• Coordinate workflow and manage project timelines to ensure all deliverables meet quality standards.

Requirements

• B.S. degree in life sciences strongly preferred (or equivalent experience as specified in the job description).
• Knowledge of laboratory testing, equipment, and procedures.
• Strong understanding of Good Documentation Practice (GDP).
• Proficiency in Microsoft Office and laboratory information systems.
• Ability to follow strict regulatory requirements including GMP, GLP, and ISO.
• Strong critical thinking, problem-solving, and attention to detail.

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.