Labware (CLMS) Administrator

Job description

The Labware Administrator/Manager is a key role at Cerba Research overall responsible for the Labware, commercial off the shelf, Central Lab Management System (CLMS) for day-to-day operational data entry and end-to-end management of central lab management activities.


Your tasks and responsibilities in the role:

CLMS Project (ATLAS)
Participate in the Atlas project to build up internal Labware CLMS knowledge and document relevant information in a consistent, systematic manner
Work closely with the project team members and Labware consultants to fully understand the Cerba Research processes and requirements and Labware CLMS capabilities
Participate and provide input in the fit/gap analysis and detailed design of Labware CLMS
Work closely with Labware consultants to fully understand Labware CLMS implementation best practices (golden rules for commercial off-the-shelf solution)
Assist with the (functional) configuration of Labware CLMS
Participate in end-user training

Governance & Compliance:
Oversee and maintain the overall design and architecture of Labware CLMS with the objective to stay close to the off-the-shelf solution
Participate in internal and external audits, providing necessary input, documentation and support
Collaborate with stakeholders and business partners to understand business objectives, goals and requirements and translate into Labware CLMS capabilities
Ensure consistency and standardization of Labware CLMS and related technologies used within the organization (e.g. Labware for CLMS, Microsoft Azure for infrastructure & hosting, TALEND for cross-system integrations and Mirth for lab interfaces) in a collaborative mode with technology and IT experts
Assure that Labware CLMS maintains the validated state and is compliant with FDA, EMA GAMP 5 regulations and meets GxP industry standards in collaboration with IT Quality and Quality

Labware CLMS Management & Business Analysis:
Map and implement business process changes and configurations in Labware CLMS in line with the change control procedures
Support in the configuration and troubleshooting of Labware CLMS
Coordinate and liaise with relevant teams and Labware for implementing changes
Monitor concurrent license usage and anticipate follow-up actions if needed
Verify Labware CLMS is functioning correctly and efficiently
Support and oversee new integrations/interfaces with Labware CLMS in partnership with the IT architect role
Create and maintain Labware CLMS documentation including user manuals, SOPs, troubleshooting guides, and training materials

Roadmap & Planning:
Establish and maintain a Labware CLMS roadmap aligned to the business goals, objectives and priorities
Translate the Labware CLMS roadmap into concrete milestones and deliverables
Closely follow-up on new Labware releases and assess features and fit-for-purpose for Cerba Research
Conduct technology watch to identify relevant innovations and trends (AI, Robotics, …) in collaboration

Desired profile

About You (qualifications, skills and experience)

Professional Bachelor or Master’s degree in Life Sciences, Engineering, Computer Science, or equivalent experience
 
Industry experience and business analysis:
Several years of experience in the Life Sciences or Healthcare industry
Experience in (functional) business analysis in a laboratory setting is a plus
Understanding and/or experience with FDA, EMA and GAMP 5 compliance

Communications and stakeholder management skills:
Excellent written and verbal communication skills
Ability to explain Labware CLMS concepts to non-technical stakeholders
Coordination skills to balance expectations and needs of different stakeholders
Experience in working in cross-functional teams
Strong collaborative skills to work with business partners and technical teams

Problem-Solving and critical thinking:
Ability to analyse problems logically and propose effective solutions
A critical thinker and experience in performing root cause analysis