Laboratory Info System Application Specialist

Job Description

Laboratory Info System Application Specialist

Full-Time

Exton PA

Frontage Laboratories:

Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position Summary:

The Laboratory Information System (LIS) Application Specialist will be responsible for implementation and maintenance of the Central Laboratory Information System, instrument middleware, and other supporting software systems for Central Lab Services.

Onsite Position

Responsibilities:

Build and maintain LIS/LIMS database for clinical trial and medical diagnostic testing and Biorepository

Assist laboratory management and QA Specialist with comprehensive Change Control related to the Laboratory Information Systems.

Liaise between laboratory management, QA, and Information Technology departments, coordinating multidisciplinary efforts

Partner with Study Setup and Project Management to build appropriate tests and calculations

Working with Senior System Administrator to develop and maintain Central Lab Service procedures regarding LIS/LIMS, middleware, and other supporting software systems

Ensure HIPAA and GDPR compliance in Central Lab Services processes in conjunction with QA and laboratory management.

Requirements:

B.A/B.S. in Biology, chemistry, or related scientific disciplines with experience in a clinical laboratory setting

Minimum of 1 years’ experience in test build

Experience with LabVantage

Experience in performing or assisting clinical laboratory testing

Working knowledge of FDA GCP, CLIA Regulations, HIPAA, CAP checklists are highly desirable

High level of accountability with self and others

Hands-on approach with a desire to teach others

Track record of challenging the status quo

Team and action-oriented

Problem-solving

Priority setting

Timely decisions

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.