Study Director I

Nelson Laboratories, LLC; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Sotera Health seeks a Study Director to lead the technical conduct of assigned tests and to review, interpret, and report results. This role serves as the single point of study control, ensuring studies are completed on time and in compliance with GMP, GLP, and ISO standards.

Responsibilities include maintaining data traceability, approving reports, and collaborating with QA, QE, and Sales. A life sciences degree and Study Director Training are required, with relevant NL laboratory experience

Qualifications

• B.S. degree (life science strongly preferred) or A.A./A.S. or equivalent with two years NL laboratory experience, or High School diploma or GED with five years NL laboratory experience.
• Successful completion of Study Director Training.
• Experience coordinating studies and ensuring tests follow procedures and regulatory requirements.

Responsibilities

• Oversee the technical conduct of all assigned tests and ensure timely completion.
• Review, interpret, analyze, and report results with final signature on reports.
• Ensure reports comply with procedures and data reflect raw data accurately.
• Maintain data traceability and participate in QA and QE processes.
• Communicate study updates and CSS details to sponsors; collaborate with Sales on testing quotes.

Skills

Lab oversight

GDP

Regulatory knowledge

Critical thinking

Communication

Attention to detail

Study Director Training

Data interpretation

Documentation

Education

B.S. degree (life science preferred)

A.A./A.S. or equivalent

High School diploma or GED

Tools

Laboratory systems

Microsoft Office

Job description

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. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Job Summary

The Study Director has overall responsibility for the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results. The study director is the single point of study control. The study director ensures all assigned studies are completed on time.

Essential Duties

Scientific/General

• Ensure reports are compliant with current procedures.
• Ensure final reports accurately reflect the data, results, and conclusions of the testing.
• Act as a final signature for assigned studies.
• Collaborate on Customer Specification Sheets (CSS) etc. as assigned.
• Ensure sample and data traceability are maintained throughout testing.
• Ensure calculations and statistics accurately reflect the raw data.
• Ensure accuracy of raw data.
• Ensure test controls and monitors are accurately recorded and reviewed.
• Collaborate within the Quality Event (QE) process.
• Read and maintain an understanding of validation procedures.
• Collaborate with document owners on Standard Test Procedures (STP) as assigned.

Regulatory Compliance

• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
• Know and follow company policies and procedures.
• Ensure that test procedures are approved, communicated to, and followed by analysts.
• Ensure all data are accurately and concurrently recorded.
• Ensure unforeseen circumstances or events are recorded and that corrective action is taken.
• Complete required training on time.

Customer Service

• Uphold the NL service standard.
• Communicate regularly with sponsors as needed to relay study updates and CSS details.
• Meet or exceed sponsor expectations.
• Collaborate with the Sales department on testing quotes.
• Maintain a general understanding of company pricing and credit policies.
• Review and update study information in CRM and/or other laboratory systems.

Project Management

• Coordinate workflow to ensure sponsor expectations are met.

Professionalism

• Keep current with technical and scientific information.
• Ensure analysts understand testing performed on behalf of the study director.
• Attend work regularly and reliably.
• Adhere to all policies and procedures.
• Perform other duties as assigned

Competencies of this position

• Technical Knowledge of laboratory testing, equipment, procedures, and basic math sufficient to direct and oversee assigned testing.
• Ability to follow written procedures.
• Good documentation practice (GDP).
• Effective critical thinking, problem‑solving, and decision‑making skills.
• Ability to learn and comprehend difficult tasks.
• Ability to troubleshoot problems.
• Attention to detail.
• Effective computer skills: Microsoft Office and laboratory systems.

Values

• Ability to work in a team environment, including the ability to give and receive feedback.
• High standards of honesty, integrity, and quality.
• Willingness to identify and communicate process improvement ideas.
• Customer‑focused attitude.
• Strong work ethic and initiative.
• Professional Effective communication skills: verbal, written, and active listening.
• Ability to organize and manage workload.
• Ability to meet deadlines

Work Environment: This job operates in a professional laboratory environment. This role routinely uses standard office equipment and lab equipment including but not limited to computers keyboards, computer mouse, telephones, photocopiers, file cabinets, microscopes, micropipettes, pipette aids, various hand tools, and analytical equipment. The possibility exists for exposure to biological and chemical hazards, exposure to carcinogenic compounds and other environmental aspects which may be considered unfavorable. Employees are expected to follow Biosafety and Chemical Hygiene policies, practices and procedures.

Travel: Occasional local travel during the business day and occasional out of the area or overnight travel may be expected.

Physical requirements: The physical demands described here are a representative of those that must be met to perform the essential job functions. Requirements to stand and traverse to various office and lab locations and sit at a computer workstation will vary. Bending, stooping, and crouching. Occasional push and pull tasks with one or both hands. Must be able to work while wearing personal protective equipment such as safety glasses, goggles, face shields, gloves, lab coats and personal protective equipment deemed necessary to protect testing and to protect employees from various solutions, wastes, etc. Must be able to lift up to 45lbs.

Education and experience requirements: B.S. degree (life science strongly preferred) or A.A./A.S. or equivalent* and two years NL laboratory experience*, or High School diploma or GED, five years NL laboratory experience* in addition to demonstrate proficiency for test coordination. Successful completion of Study Director Training.

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.

Sotera Health is driven by its mission, Safeguarding Global Health®. Along with our three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs® – we are a leading global provider of mission‑critical end‑to‑end sterilization solutions and lab testing and advisory services for the healthcare industry.