LIS Application Specialist

Frontage Laboratories, Inc.; Exton (PA); On-site; USD 65,000 - 90,000; Full time

Job summary

Frontage Laboratories Inc. is seeking a LIS Application Specialist in Exton, PA to develop and maintain Central Lab LIS/LIMS systems for clinical trials.

The role requires a Bachelor's in Biology or Chemistry, at least 1 year LIS/LIS Setup experience, and familiarity with LabVantage Medical Suite and Biobanking. You will collaborate with QA, IT, and operations to ensure regulatory compliance and data integrity.

Qualifications

• Bachelor’s degree in Biology, Chemistry, or related field.
• At least 1 year LIS/LIS Setup experience.
• Experience with LabVantage Medical Suite and Biobanking preferred.

Responsibilities

• Develop and maintain Central Lab Service LIS/LIMS procedures and training materials.
• Build and maintain LIS/LIMS databases for clinical trials and Biorepository.
• Collaborate with Laboratory Operations and Project Management on LIS/LIMS tests and calculations.
• Support Change Control processes for Laboratory Information Systems.
• Liaise with QA, IT, and management to coordinate multidisciplinary efforts.
• Ensure compliance with HIPAA, GDPR, GCP, GLP, CAP, CLIA, and related regulations.
• Interface with Data Management to ensure data transfer accuracy.
• Design protocol-driven studies in LIS/LIMS to meet client needs.
• Identify and resolve technical issues with LIS/LIMS systems.
• Assist Bio Analytics Sample Management with study design and sample login in WATSON or LabVantage.
• Manage users and security in central lab systems.
• Document incidents and resolutions in ticketing system.
• Communicate workload and priorities to supervisor.
• Perform other duties as assigned.

Skills

LIS/LIMS setup

Data management

Regulatory compliance

Education

Bachelor's degree in Biology or Chemistry

Tools

LabVantage Medical Suite

Biobanking

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

LIS Application Specialist

Full Time Exton, PA, US

8 days ago Requisition ID: 1865

Location:Exton, PA

Full-time

Frontage Laboratories:

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.

Duties/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.

Education/Experience 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.
• Experience with LabVantage Medical Suite and Biobanking preferred.

Salary and Benefits:

Frontage Laboratories offer a competitive compensation and benefits package including.

• health and dental insurance
• 401(k) plan
• disability insurance
• life insurance

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.