Study Director I

Sotera Health•Itasca, IL

2d•$22 - $35•Hybrid

About The Position

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. The Study Director is an individual contributor role that serves as the key connection between customers and laboratory teams, ensuring testing is clearly understood, properly coordinated, scientifically sound, and completed in alignment with customer and regulatory requirements. This role supports current and upcoming opportunities across specialized laboratory teams, translating customer requirements into clear direction for laboratory teams and coordinating study activities from initiation through final reporting.

Requirements

Bachelor’s degree, with a degree in life sciences or a related scientific field strongly preferred
Associate degree or equivalent combined with relevant laboratory experience
Significant relevant laboratory experience combined with demonstrated proficiency in study coordination
Experience in laboratory testing, life sciences, medical devices, pharmaceuticals, biotechnology, quality, regulated environments, technical customer service, or scientific project coordination may be beneficial.
Laboratory testing, equipment, and procedures
Good Documentation Practice (GDP)
GLP, GMP, ISO, or other regulated quality environments
Data and report review
Critical thinking and problem-solving
Project and workflow coordination
Customer communication
Technical writing and documentation
Microsoft Office and laboratory information systems
Managing multiple priorities and deadlines

Nice To Haves

Enjoy working directly with customers and building trusted professional relationships
Can understand technical or scientific requirements and communicate them clearly
Are comfortable coordinating multiple studies, priorities, and deadlines
Have strong attention to detail and documentation skills
Can review data critically and identify inconsistencies or potential issues
Enjoy solving problems and troubleshooting
Communicate effectively with both technical and non-technical stakeholders
Work well across laboratory, quality, sales, and customer-facing teams
Take ownership of projects and follow through on commitments
Are comfortable working in a regulated, procedure-driven environment
Can balance scientific quality, customer expectations, and timelines

Responsibilities

Serve as a primary point of contact for customers regarding assigned studies
Meet with customers to understand testing needs, study requirements, timelines, and expectations
Translate customer requirements into clear direction for laboratory teams
Coordinate study activities from initiation through final reporting
Maintain regular communication with customers regarding study progress, updates, and questions
Review, interpret, analyze, and document study data and results
Ensure final reports accurately reflect testing data, results, and conclusions
Review raw data, calculations, statistics, controls, and study documentation for accuracy
Maintain sample and data traceability throughout testing
Ensure testing is conducted according to approved procedures and applicable requirements
Collaborate with laboratory analysts to ensure study requirements and testing expectations are understood
Identify, document, and help resolve unexpected circumstances, deviations, or quality events
Partner with Sales and other internal teams on testing requirements, quotes, and customer needs
Update study information in CRM and laboratory systems
Coordinate workflow and priorities to support customer expectations and study timelines
Contribute to continuous improvement of procedures, documentation, and laboratory processes