Study Director II: Lead Complex Scientific Studies

Nelson Laboratories, LLC; Salt Lake City (UT); On-site; USD 110,000 - 140,000; Full time

Job summary

Sotera Health is seeking an experienced Study Director II to serve as the scientific and operational lead for medical device and healthcare-related testing studies. You will oversee the technical conduct of assigned studies from initiation through final reporting, ensuring scientific quality, regulatory compliance, and exceptional customer service throughout the process.

As the primary point of accountability for assigned studies, you will work closely with customers, laboratory personnel,

Qualifications

• Master's degree in Life Sciences or related field preferred.
• Bachelor's degree with Study Director experience acceptable.
• Associate degree (or equivalent) with at least 3 years laboratory experience as Study Director.

Responsibilities

• Serve as the primary scientific lead and single point of control for assigned studies.
• Direct the technical execution of studies from initiation through final report issuance.
• Review, interpret, analyze, and communicate study results.
• Prepare, review, and approve technical reports and study documentation.
• Collaborate on test method development, validations, and equipment validations.
• Review and approve customer specifications and study requirements.
• Serve as a document owner for assigned standard test procedures and laboratory documentation.

Skills

Strong technical writing

Scientific communication

Experience leading scientific studies

Customer interaction management

Project management

Regulated laboratory experience

Education

Master's degree in Life Sciences or related field

Bachelor's degree in Life Sciences with Study Director experience

Associate degree with 3+ years lab experience as Study Director

Job description

Sotera Health is seeking an experienced Study Director II to serve as the scientific and operational lead for medical device and healthcare-related testing studies. You will oversee the technical conduct of assigned studies from initiation through final reporting, ensuring scientific quality, regulatory compliance, and exceptional customer service throughout the process.

As the primary point of accountability for assigned studies, you will work closely with customers, laboratory personnel,