Senior IT Consultant (m/f/n)

Project name 

CTS-2 Signant and Prisym Implementation

Project description

This project shall implement the two software packages SmartSignals Supplies of Signant Health and PRISYM 360 of PRISYM ID for clinical trial supply (CTS) functionalities as successor of the existent Clinical Trial Supply System CTSS.

Key capabilities of the systems:

• Material management
• CTS Study Design
• CTS Forecasting & Planning
• CTS Label design & approval
• CTS Outsourcing
• Medication kit list, Randomization generation
• Batch Recording, Process orders
• Warehouse management ,Distribution
• Depot-to-site traceability
• CTS Batch Release
• Quality processes

Background to the assignment

The service of the contractor is delivered using an agile working method. External resources are needed as the scope of the CTS solution exceeds by far the scope of the preceding system and there is no experience inhouse with regards to system functionality and integration. Therefore, the external consultant is in a unique position and performs significantly different tasks than the internal employees.

Project set up
-   Daily standups, 15 mins, 3 times per week
-   During the daily standup, all team members exchange on their progress towards the sprint goals, raise blockers and adapt the course of action if necessary to achieve sprint goals.
-   Biweekly Sprint Review, on average 60 mins, with all stakeholders. During the sprint review, the team inspects the product increment developed during the sprint and the findings generates as a result of the research, if necessary. Team also presents to the stakeholders an overview of the work done during the sprint, and answers their questions.
-   Monthly Sprint Retrospective, on average 2 hours. All team members discuss how the previous sprint went, what challenges occurred and actions for the next sprint are defined to ensure continuous improvements of the teams processes.
-   Biweekly Sprint Planning, 2 hours. The Product Owner and the Development Team define what will be the tasks for the next sprint, based on the availability, priorities and users feedback.
-   Participation of meetings with users, Signant Health and IT based on Biweekly Sprint Planning


Project set up will be discussed and reviewed. A change from full scrum to a more hybrid approach is likely. 


Concrete, detailed description of services
During the sprints, the team discusses the current requirements and the contractor independently performs the following tasks:

• MBR, Master data and Configuration consulting
  • Analysis and draft documentation of CTS processes, will be approved by BI project team
  • Map these processes in the software based on the documentation of CTS processes and sprint planning, guided by Signant Health consultants how to enter data properly
  • If necessary, provide system configuration in SmartSignals Supplies of Signant Health and PRISYM 360 of PRISYM ID based on the documentation of CTS processes and sprint planning, guided by Signant Health consultants how to enter configuration properly. Configuration will be tested and accepted by BI
• SAP interface
  • Draft documentation of interface processes. Documentation will be approved by BI project team
  • Technical consultation of the project team regarding interface specifications
  • Compile test specification based on the documentation of CTS processes, system documentation and sprint planning. Test specification will be reviewed and approved by BI
  • Dry-run testing and test execution. In case of test failure, addressing of issues in sprint meetings
• Interfaces SignantHealth to other Cloud providers, e.g. CTMS, IRT's, other CRO
  • Draft documentation of interface processes. Documentation will be approved by BI project team
  • Technical consultation of the project team regarding interface specifications
  • Compile test specification based on the documentation of CTS processes, system documentation and sprint planning. Test specification will be reviewed and approved by BI
  • Dry-run testing and test execution. In case of test failure, addressing of issues in sprint meetings
• Interface SignantHealth - PRISYM 360
  • Draft documentation of interface processes. Documentation will be reviewed by BI project team
  • Compile test specification based on the documentation of CTS processes, system documentation and sprint planning. Test specification will be reviewed and approved by BI
  • Dry-run testing and test execution. In case of test failure, addressing of issues in sprint meetings
• Set up of data fabric for CTS data
  • Draft documentation of requirements. Documentation will be reviewed by BI project team I
  • Technical consultation of the project team regarding interface specifications Signant - data fabric
  • Dry-run testing and test execution. In case of test failure, addressing of issues in sprint meetings
• Generation of Reports based on data fabric
  • Creation of report specification as discussed in the sprint meetings to enhance reporting capabilities of SmartSignals Supplies of Signant Health and PRISYM 360 of PRISYM ID.
  • Implementation of reports using Tableau software based on specification of reports 
  • Compile test specification based on the documentation of CTS processes, report documentation and sprint planning. Test specification will be reviewed and approved by BI
  • Dry-run testing and test execution. In case of test failure, addressing of issues in sprint meetings
• UAT and System Validation 
  • Compile test specification based on the documentation of CTS processes, system documentation and sprint planning. Test specification will be reviewed and approved by BI
  • Test execution. In case of test failure, addressing of issues in sprint meetings