- We are looking for a LIMS Business analyst with competences in Computer System Validation.
- Within the LIMS Deployment & User Support team at one of or clients, the LIMS Business Analyst will take part in the deployment and the life-cycle of IT solutions to manage Biological Samples, assays definition and lab testing activities.
- Support the system's end users:
- Act as the single point of contact between business and IT
- Follows IT incidents
- Assess the root cause incidents and their impact on data and processes
- Take part to the definition of incident resolution priority (based on risk)
- Ensure proper follow-up and communication to stakeholders
- Implement corrections and improvements within the system:
- Collect and challenge business requirements
- Assess relevancy and criticality of business requirements
- Write users requirements
- Assess the impact of a change within the system (on documents, on process...)
- Plan waves of corrections and improvements
- Test the corrections/improvements delivered by the IT department
- Draft System Acceptance Test Protocols
- Create date sets and execute system validation
- Train users on new functionalities
- Ensure adequate communication to users
- Perform complex analysis on data as well as tests/simulations within the test environment
- Ensure permanent validation state of the system through the execution of periodic compliance reviews
- Perform user mappings to ensure that the right users have the right accesses
- Act as system experts during IT projects:
- Take active part to workshops
- Take part to the system informal testing and validation phases
- Become the experts of the new solution deployed
Required Experience & Knowledge :
- At least 3 years of experience in a similar position, preferably in GLP environment
- Demonstrable knowledge of the regulated pharmaceutical industry and the computer compliance regulations and expectations that apply to clinical research processes
- Possess excellent planning and organizational skills
- Demonstrate effective problem solving and decision making
- Able to build and maintain effective internal business relationships with the different stakeholders
- Able to work in a matrix organization
Soft skills :
- Team player and autonomous
- Effective and influential communicator, both in writing and verbally
- Able to identify and express compliance risks in the context of a business process
Education, Methodology & Certification Requirements:
- Qualified with a Bachelor’s degree in scientific discipline or equivalent.
- Have a working knowledge of one or more of GLP/GCP/GMP/PV regulations
ICT Skills (software, operating systems, hardware, etc.):
- Office Tools
Language Proficiency Requirements:
- English: Fluent
- French is a plus
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.