Summary:
Responsible for setting up clinical trials in the iDARTs application, an internally developed tool for medical review of clinical trial data based on TIBCO’s Spotfire.
At the trial level, perform the following activities:
• Analysis, design and data mapping of new trials for iDarts
At the Therapeutic Area level:
• Contribute to the further improvement of our template library
• Function as daily liaison between Clinical team members and the iDarts development and implementation team
Responsibilities :
• Analysis and design of iDarts for new studies
• Design visualizations in line with study protocol specifications and translate them to specifications
• Data mapping of iDarts for new studies
• Map iDarts data visualizations to the clinical trial database. SDTM knowledge is a big asset.
• User Acceptance Testing of iDarts
• Test new study set-up in iDarts before release in to production
• Team responsibilities for iDarts implementation
• Help ensure that all new studies are set-up in iDarts on time.
• Provide feedback where needed if questions arise during iDarts set-up
• Function as liaison between Clinical team members and the iDarts development and implementation team
• Identify additional needs for medical review, currently not supported by iDarts
• Provide input to the iDarts IT group
• Follow-up on needed improvements and changes needed
EDUCATION & EXPERIENCE REQUIREMENTS:
• BS/BA degree or professional experience equivalent
• Good knowledge of TIBCO Spitfire
• Minimum of 3 to 5 years of pharmaceutical or health care experience, including data analysis.
• Good understanding of Clinical trials (including database structures & design)