emagine is currently seeking a Support Research SME for designing and implementing an IT-system for one of our clients in the pharmaceutical industry.
Job Description
Support the implementation of a single IT system to support sample management, sample analysis, and reporting of PK/bioanalysis, immunogenicity assessment, and biomarkers for regulated non-clinical and clinical studies. The goal of the solution is to achieve twice as much in half the time enabling about 100 people.
The project is currently implementing LabVantage LES (laboratory execution system) to make a paperless lab. This entails a digital documentation of used reagents, chemicals, and instruments in an electronic setup scheme. This will eventually be used to investigate compliance issues or be reported upon in reports. The first part of the project is implemented and the second part, creating LES method for reagent creation and sample analysis, is the task that should worked upon to support. This involves understanding business requirements, document these as workflows, users stories and ensure that they are writing as functional specifications.
Required Skills
Agile/Safe working style
Azure DevOps
Requirements gathering in workshop or input from SMEs
Create documentation: On business process/workflows, use cases, user stories and functional specifications
Collaborate with Developers and SMEs to design solution
Miro or similar for process mapping
Be excellent in asking questions to understand business processes
GLP/GCP
IT Validation activities including collaboration with Validation responsible persons and testers
Start date: 19th of January 2025
End date: 18th of January 2026
Allocation: Full time, time & material
Location: Måløv, Denmark
