Study Director I
About the role
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry.
Responsibilities
- Serve as the key connection between our customers and laboratory teams, helping ensure testing is clearly understood, properly coordinated, scientifically sound, and completed in alignment with customer and regulatory requirements.
- Serve as a key point of coordination and communication for assigned laboratory studies.
- Work closely with customers, laboratory teams, and internal partners to help ensure studies are clearly defined, properly executed, accurately documented, and completed on time.
- Depending on your assigned laboratory area, you may 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.
- Coverage 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.
- Avoidance of ensuring 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.
- Possess collaboration 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.
Qualifications
- Strong Study Directors combine scientific understanding with communication, organization, and customer service.
- You may be a strong fit if you enjoy working directly with customers and building trusted professional relationships.
- Understand technical or scientific requirements and communicate them clearly.
- Be comfortable coordinating multiple studies, priorities, and deadlines.
- Have strong attention to detail and documentation skills.
- 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.
- Be comfortable working in a regulated, procedure-driven environment.
- Balance scientific quality, customer expectations, and timelines.
Skills
- Experience or aptitude in areas such as: 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.
Benefits
Commensurate with experience.
Pay
The hourly pay range for this position is $22.12 to $34.62. The starting rate for a successful candidate will be determined based on job-related qualifications, skills, experience, education, certifications, internal equity, and market conditions. While the full range reflects the potential earning opportunity for the role, new hires are typically placed within a portion of the range that is appropriate for their qualifications and experience.
Schedule
Nightly shift.
Why Join Us?
- Study Directors play a critical role in connecting customer needs with laboratory execution.
- You will have the opportunity to work at the intersection of science, customer partnership, and project coordination while supporting testing for the medical device and pharmaceutical industries.
- This role can be an excellent fit for laboratory professionals who want to expand beyond primarily bench-based work, as well as science professionals who enjoy customer interaction, technical problem-solving, and coordinating complex projects.
Work Environment & Physical Requirements
- This position operates in a professional laboratory environment and may involve the use of standard office and laboratory equipment.
- Depending on the assigned laboratory area, employees may be exposed to biological or chemical hazards and are expected to follow all applicable biosafety, chemical hygiene, and personal protective equipment requirements.
- The role may require standing, walking between office and laboratory areas, sitting at a computer workstation, bending, stooping, crouching, occasional pushing or pulling, and lifting up to 45 pounds.
- Occasional local or overnight travel may be required.
Company Information
Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.