IT Senior Application Analyst-Central Lab Services
Job Title: Senior Application Analyst – Central Lab Services
Reports To: Vice President, Pathology and Clinical Informatics
Remote Position: Yes, onsite when required
• The Senior Application Analyst – Central Lab Services will be responsible for implementation and maintenance of the Central Laboratory Information System (LIS)/Laboratory Information Management System (LIMS), instrument middleware, and other supporting software systems for Central Lab Services.
• Assist in the selection of Central Lab Services applications and systems
• Serve as the Subject Matter Expert for the LIS/LIMS and other laboratory software systems, including instrument interfaces
• Assist laboratory management and QA Specialist with comprehensive Change Control (IT and Laboratory Processes)
• Liaise between laboratory management, QA, and Information Technology departments, coordinating multidisciplinary efforts
• Build and maintain LIS/LIMS database for clinical trial and medical diagnostic testing
• Partner with Study Setup and Project Management to build appropriate tests, calculations, etc for each Clinical Trial
• Develop and maintain Central Lab Service IT procedures regarding LIS/LIMS, middleware, and other supporting software systems
• Assess overall compliance with protocols, SOPs, policies, and applicable regulations
• Ensure HIPAA and GDPR compliance in Central Lab Services IT processes in conjunction with QA and laboratory management.
• B.A/B.S. in Biology, chemistry, or related scientific disciplines with experience in a clinical laboratory setting
• Minimum of 4 years’ experience assisting with or managing a quality management system in a regulated environment; clinical laboratory experience and clinical trial experience highly desired
• Working knowledge of FDA GCP, CLIA Regulations, HIPAA, CAP checklists are highly desired
ESSENTIAL SKILLS include the following.The skills listed below are representative of those that are required to perform this job successfully.
• 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
• Priority setting
• Timely decisions