Description
Spotfire .NET DeveloperiDARTs (Intuitive Data Analysis Reporting Tools), a software system with significant potential to improve clinical trial medical reviews.
Medical reviews are conducted to insure consistency in patient medical data and adherence to study protocols and Good Clinical Practices. iDARTs, which is being developed as part of the JEDI Transform Trial Design initiative, represents an effort to implement a single, validated system across all Therapeutic Areas (TAs) for conducting clinical trial medical reviews.
Strengthening compliance and efficiency
The objectives of iDARTs are to strengthen regulatory compliance and operational efficiency while reducing costs.
- iDARTs enhances compliance by introducing a validated tool, standardized analytical framework and a systematic approach to medical reviews.
- Operational efficiency will benefit from improved communication and collaboration between the site managers, data managers and reviewers involved in medical reviews. iDARTs also will improve processes for tracking reviewed data, updating and annotating data, and reconciling safety data.
- Implementation of iDARTs will decrease costs by eliminating the need for multiple legacy tools and enabling the use of reusable data components that will speed the setup process for medical reviews.
- Identifying potential safety issues proactively
iDARTs is intended to help medical reviewers identify and track potential safety issues far more proactively. The visualization capabilities of iDARTs will make it easier for medical reviewers to regularly evaluate data representing hundreds or thousands of study participants. This will enable reviewers to spot potential trends and review patient data in greater
detail at earlier points in a trial.
You will be part of the development team that works out extensions on top of SPOTFIRE to be able to handle Review status, Inquiries immediately together with the visualization.
Technical skills:
• Spotfire basic authoring
• Spotfire API knowledge
• Ironpython scipting
• .NET development (C#)
• ASP.NET development
• SQL
Personal skills:
- work independently
- work very critical
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management for internal guidelines.
Language proficiencies:
- English and Dutch spoken and written;