Laboratory Information Systems (LIS) Manager

Proclinical is currently recruiting for a Laboratory Information Systems (LIS) Manager with a leading CRO company located in San Diego, CA. As the LIS, you will collaborate with the Laboratory Director, Histopathology Supervisor, and laboratory staff to ensure lab activities and support are integrated into the strategic and tactical planning.

Job Responsibilities:

• Responsible for the Laboratory Information Systems (LIS) being developed, including all integrated platforms.
• Ensure that all activities related to LIS modifications and operation follow industry best practice and are documented in alignment with regulatory expectations
• Serve as the management liaison responsible for the evaluation, implementation, maintenance, and enhancement of LIS components.
• Oversee LIS project management, client interactions and generation of IT projects affecting LIS.
• Ensure completion and follow-up of user requests that involve LIS. Oversee resources-allocation and evaluate need for resources (servers, licenses, new interfaces etc.) short and long-range planning.
• Assist in the recommendation and design of custom or commercial hardware and software solutions.
• Identify and develop functionality to support new regulatory, workflow process and documentation improvement.
• Ensure issues logged about the Lab IT systems are resolved in a timely manner.
• Maintain current documentation as needed to meet all pertinent information system requirements for all laboratory and clinical trials accrediting agencies as it pertains to the computer systems and validation.
• Selects, implements, maintains and operates security mechanisms such as firewalls, antivirus methods, anti-malware software and system back-up

Skills and Requirements:

• Minimum BS or BA; preferred: Master's degree in a related informatics or laboratory science.
• Knowledge of operational workflows for the laboratory.
• Knowledge of relevant compliance and regulatory requirements related to clinical trials, especially 21 CFR Part 11, FDA Good Clinical Practice (GCP) and regulatory documentation requirements.
• Knowledge of HL7 and instrument interfaces.
• Experience implementing medium-sized laboratory LIS systems.
• Experience with SQL Server Management
• Experience with Laboratory Information Systems
• Skilled in MS Office tools: Word, Outlook, Excel, PowerPoint, Access, and Visio.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 617-903-7746 or m.robinson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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