LIS Application Specialist - Central Lab Services
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, a 401(k) plan, disability insurance, and 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.
Skills Required
- Bachelor's degree in Biology, Chemistry, or related field (or relevant work experience)
- At least one year LIS setup working experience
- Experience with LabVantage Medical Suite
- Biobanking experience
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
