LIS Application Specialist

Frontage Laboratories•Exton, PA

3d•Onsite

About The Position

Frontage Laboratories Inc. is an award-winning, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. The LIS Application Specialist will independently develop and maintain Central Lab Service standard procedures and training Job-Aids regarding LIS/LIMS, middleware, and other supporting software systems. This role involves building and maintaining LIS/LIMS databases for clinical trials, medical diagnostic testing, and Biorepository, and partnering with Laboratory Operation and Project Management to build appropriate tests and calculations. The specialist will also assist laboratory management and QA Specialist with comprehensive Change Control related to the Laboratory Information Systems, and liaise between laboratory management, QA, and Information Technology departments. Ensuring Central Lab Services instruments and systems follow relevant regulations and requirements (HIPAA, GDPR, GCP, GLP, CAP, CLIA, etc.) in conjunction with QA and laboratory management is crucial. The role also involves working with the Data Management team to ensure uniformity and accuracy between LIS/LIMS and client data transfer agreements, building and maintaining multifarious, protocol-driven studies within LIS/LIMS databases, and identifying and resolving technical difficulties with LIS/LIMS databases. Assistance with Bio Analytics Sample Management team for study design and sample login within the WATSON system or LabVantage, and administration of users and security of central lab systems are also key responsibilities. Documenting LIS system related incidents and resolutions in the IT support ticket system or logbooks, and timely communication with the supervisor on workload and task prioritization are expected. Other tasks may be assigned.

Requirements

Bachelor’s degree in related fields such as Biology, Chemistry, or relevant work experience in similar fields.
At least one year LIS Setup working experience.

Nice To Haves

Experience with LabVantage Medical Suite and Biobanking preferred.

Responsibilities

Independently develop and maintain Central Lab Service standard procedures and training Job-Aids regarding LIS/LIMS, middleware, and other supporting software Systems.
Build and maintain LIS/LIMS database for clinical trials, medical diagnostic testing, and Biorepository.
Partner with Laboratory Operation and Project Management to build appropriate tests and calculations in central lab LIS/LIMS systems.
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.
Ensure Central Lab Services instruments and systems follow relevant regulations and requirements (HIPAA, GDPR, GCP, GLP, CAP, CLIA, etc.) in conjunction with QA and laboratory management.
Work with Data Management team to ensure uniformity and accuracy between LIS/LIMS and client data transfer agreements.
Build and maintain multifarious, protocol driven, studies within LIS/LIMS databases in accordance with the appropriate Study protocol and Laboratory manuals to ensure all client needs are met.
Identify, analyze, and take corrective action for technical difficulties with LIS/LIMS databases experienced by Laboratory personnel or clients.
Assist Bio Analytics Sample Management team with study design and sample login within the WATSON system or LabVantage
Administrate users and security of central lab systems.
Document LIS system related incidents and resolutions in IT support ticket system or logbooks.
Timely communicate with supervisor on workload and prioritize tasks according to project timelines.
Other tasks as assigned.