Temp, Application Analyst

Overview

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.


The Laboratory Information Systems (LIS) Temp, Application Analyst is responsible for the timely set up of all aspects of clinical testing to support new and existing clinical trial studies. They will participate in all discussions and decisions, internal and external, related to study initiation and support. They will aid co-workers with complex problem research, troubleshooting, and resolution related to clinical testing to provide best-in-class support to our internal and external clients. They will administer daily operational support, assist with the planning and implementation of software enhancements.
This is a temporary role, anticipated to last 4–6 months, with a Monday–Friday business hours schedule and the option to work remotely or from our Johnson City office.


Essential Duties and Responsibilities

• Maintain the integrity and security of all data within the LIMS.
• Collaborate with clinical laboratories in the design, build, and validation of all testing components.
• Responsible for verification testing and validation documentation for clinical tests and panel builds.
• Responsible for accuracy and following procedure in the clinical trial database set up to ensure consistency and quality of data.
• Review and analyze data flow between internal application and debugging to support clinical trials tests.
• Assist in debugging Health Level 7 (HL7) and other interface messages as appropriate.
• Collaborate with internal Integration Team to validate, monitor, and troubleshoot electronic interfaces and imports from Partner Laboratories.
• Provide technical support to project team members; handle complex application features and technical designs.
• Implement solutions and/or redefine workflows to maximize the functionality of systems.
• Identify and improve business processes and support critical business strategies by assisting in the LIMS development, implementation, and maintenance for clinical trials tests.
• Support billing functions in collaboration with the Project Manager and Finance Department.
• Create/Update SOPs and policies for laboratory computer and LIMS applications.
• Keep validation documentation up to date for the LIMS.
• Develop and maintain proper procedure manuals for the department.
• Rely on extensive experience and judgment to plan and accomplish goals.
• Provide LIMS training to new and current employees as needed.
• Participate in regular meetings with LIS personnel to exchange progress reports.
• Maintain confidentiality of information in accordance with company policies and procedures.
• Perform additional tasks as needed related to the IT and LIS mission.


Education and Experience

• Bachelor's Degree, or 3-4 years related laboratory information system experience.
• Experience in the clinical laboratory and/or clinical trial industry and/or training, or equivalent combination of education and experience.
• Preferred: Experience in FDA 21CFR11/GCP.
• Preferred: Experience with Sapio LIMS system.

Skills and Ability

• Excellent attention to detail and ability to adapt to changing environments and requirements, and customer service/client relationship management skills.
• Ability to adhere to established timelines, processes, and procedures.
• Self-motivated and ability to work well independently as well as using a collaborative team approach.
• Excellent organization, time management skills, communication, multitasking, and interpersonal skills.
• Excellent listening and verbal comprehension skills, including the ability to translate client needs to team members.
• Strong planning and problem-solving skills
• Ability to make quick but well-thought-out decisions.
• Proficient in Microsoft Word, Excel, and database software.


Supervisory Responsibilities: This position has no supervisory responsibilities.

Physical Demands:

While performing the duties of this job, the occupant is regularly required to:

• Pr