Labware Administrator
Il y a 3 mois
**The Labware Administrator/Manager is a key role at Cerba Research overall responsible for the Labware, commercial off the shelf, Central Lab Management Solution (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 with the Data & Digital team
**Labware CLMS Support**:
- Serve as the primary contact with Labware Technical Support Services and the Labware Customer Success Management team
- Assist Labware and technical/operational teams in resolving incidents and issues
**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
**About us**
Cerba Research is more than just a place of work; it is an organization of committed individuals united by a passion to advance world health. Serving clients in the global pharmaceutical and biotech industries, we are experts in serological, virological, and molecular approaches and work with a variety of viruses. Our experts are actively involved in international vaccine and antiviral research programs and is renowned for producing high-quality work that is supported by comprehensive virological and immunological research. As an equal opportunity employer, Cerba Research is fully devoted to promoting your professional growth and development.
**If you are ready to tak
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Labware (Clms) Administrator
Il y a 2 mois
Gent, Belgique CERBA RESEARCH NV Temps plein**vacancy_web_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...