Aministrator (LIMS)

Location: Belgium

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Clinical Research organization, based in Brussel Belgium.

You will be working for one of the leading companies in the biopharmaceutical industry,

ROLE DESCRIPTION

You will be responsible for the implementation of the new LIMS system and daily ensuring that the system is maintained in a state which meets current regulatory expectations. This will involve technical writing and attention to detail for the maintenance of SOPs and execution of validation protocols. Routine updates to the system for new methods and material will be processed following requests from laboratory management and SME’s.

RESPONSIBILITIES

• Actively participates in the implementation of the new LIMS system for PCRU.
• Researches, validates, and supports new and existing LIMS/PIMS peripheral hardware such as barcode scanners, label printers, handheld devices,
and electronic notebooks.
• Provides daily technical support to LIMS users in support of Safety laboratory operations.
• Oversees and directs operation of the LIMS/PIMS systems and all computer applications that interface and interact with the LIMS/PIMS systems.
• Manages and groups data files by instrument in LIMS. Installs and updates instruments in LIMS and troubleshoots any issues that trace back to folder
management.
• Creates and/or reviews data management documents
• Creates and maintains custom reports in LIMS
• Executes periodic scripts or SQL extracts
• Scripts and provides extraction of data to Oracle Clinical (OC)
• Tests LIMS calculations and reflex orders twice yearly.
• Supports the LIMS interfacing of all new analyzers with the input of Instrument Owners. Sets up and maintains the active instrument folders, LIMS
scheduled tasks and the instrument interfaces
• Troubleshoots issues with the data in and between LIMS and PIMS. Works closely with the PIMS users.
• Develops and manages LIMS/PIMS improvement projects. Participates in cross-site implementation of new LIMS/PIMs features and enhancements.
• Develops relationships with vendors to identify and leverage training opportunities. Creates and updates training materials as changes to system occur.
Conducts trainings for new end users. Ensures that the LIMS/PIMS complies with all relevant regulatory standards.
• Aligns and communicates with the relevant stakeholders for all project and delivers projects in close collaboration with all parties involved (business and
IT, internal and external partners).
• Supports audits and inspections to provide data and information on request.

REQUIREMENTS

Bachelors degree in Computer Science with preferred five (5) years of experience, Information Systems Management, Internet Technology or related
field of study preferred. Work experience in a laboratory environment is a plus.

Fluency in :
o Oracle SQL (PL/SQL to a lesser degree)
o System set-up, testing and programming experience
o Quest TOAD
o Electronic Clinical and Lab Data Management System
o Business Objects Crystal Reports
o Visual basic-style script development

Understanding of :
o N-tier system architecture
o Programming concepts
o Clinical testing concepts

• Understanding of local regulatory requirements (e.g. ICH, GCP) is a plus
• Understanding of the drug development process is a plus
• Laboratory instrumentation and middleware (Data Innovations, Dawning Technologies) used to connect instrumentation to a Lab Information System.
• Fluent in English
• Experience with managing projects

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.