Study Director I

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.

Study Director

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
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