Senior Study Director – Medical Device Studies

Nelson Laboratories, LLC; United States; On-site; USD 100,000 - 150,000; Full time

Job summary

Sotera Health, including Nelson Labs, seeks a Study Director II to lead complex medical device and healthcare-related testing studies. You will serve as the scientific and operational leader from initiation to final reporting, ensuring quality, regulatory compliance, and exceptional customer service.

The ideal candidate will combine strong scientific expertise with outstanding communication and project leadership skills, capable of interacting with customers, interpreting data, and managing

Qualifications

• Master's in Life Sciences or related field required or equivalent experience.
• Bachelor's in Life Sciences with Study Director experience considered.
• Associate degree with minimum three years as Study Director in a laboratory.

Responsibilities

• Lead scientific studies from initiation through final report with regulatory compliance.
• Serve as primary contact for study-related scientific discussions with customers.
• Coordinate across laboratories and departments to keep studies on schedule.
• Ensure all studies meet GLP, GMP, and ISO-regulated requirements.
• Provide mentorship to junior staff and support training and development.

Skills

Scientific reasoning

Analytical skills

Technical writing

Verbal communication

Project management

Customer relations

Cross-functional collaboration

Problem solving

Leadership

Education

Master's in Life Sciences

Bachelor's in Life Sciences with Study Director exp

Associate degree + 3 years Study Director lab exp

Job description

Sotera Health, including Nelson Labs, seeks a Study Director II to lead complex medical device and healthcare-related testing studies. You will serve as the scientific and operational leader from initiation to final reporting, ensuring quality, regulatory compliance, and exceptional customer service.

The ideal candidate will combine strong scientific expertise with outstanding communication and project leadership skills, capable of interacting with customers, interpreting data, and managing