Clinical Trial Informatics SME
- Expertise in data and tools used for clinical trial planning, monitoring and organization, including Case Report Forms, Electronic Data Capture, and Clinical Trial Management Systems (such as Medidata Rave).
- Experience with medical monitoring of trials and QC/curation of patient data prior to statistical analysis.
- Knowledge of trial inclusion/exclusion criteria and enrollment metrics, and experience with commercial databases such as TrialTrove/SiteTrove.
- Ability to work with clinical trial managers to elicit and document requirements for new software applications, and communicate those requirements to technical teams.
- Ability to query clinical databases and generate data tables for analysis and QC.
- Experience in operations of clinical trials in oncology and/or autoimmune diseases.
- Effective written and oral communication skills.