Study Director II

Sotera Health•Salt Lake City, UT

3d•Onsite

About The Position

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. A Study Director II must have sufficient scientific knowledge and communication capabilities to build and maintain customer relationships. A Study Director II will represent well the testing they oversee both verbally and in writing. He/she may also be assigned supervisory responsibilities while in this role.

Requirements

All requirements, as outlined in the Study Director I job description in addition to the following:
Technical Medical Device, Pharmaceutical, and Biomedical Industry knowledge as relates to section and testing offerings.
Understanding of company structure and imperatives.
Basic financial acumen and NL business understanding.
Conflict management skills
Presentation skills
Supervisory skills
Effective communication skills specific to technical concepts, problem identification, and solutions.
Demonstrated effective technical writing ability.
M.S. degree (life science strongly preferred) or B.S. degree (life science strongly preferred), and a minimum of one year Study Director I experience or A.A./A.S. or equivalent and three years NL laboratory experience as a Study Director I
Successful completion of Study Director Training

Responsibilities

Ensure final report templates (FRTs) are compliant with procedures.
Collaborate, review, and approve Customer Specification Sheets (CSS).
Collaborate on the test method and equipment validations.
Act as document owner for Standard Test Procedures (STP) as assigned.
Supervise and manage as assigned.
Resolve assigned Quality Events (QE).
Assist in hosting laboratory auditors and other visitors.
Review current technical and scientific information and contribute content to publications as assigned.
Collaborate with Sales on project estimates and customized quotes as needed.
Communicate business strategy, product life cycle, and laboratory offerings to customers.
Communicate with sponsors regarding a resolution of service and testing issues (e.g., quality events, turnaround time, concerns, etc.).
Coordinate with sponsors and other sections regarding test requirements for routine and non-routine studies.
Perform all other duties as assigned.