Education and Experience Requirements/Qualifications:
Base Level:
• Bachelor’s degree or equivalent, preferably in Computer Science.
• Minimum of 8 to 17 years’ experience building EDC databases in support of clinical research.
• Technical EDC build experience using Medidata Rave.
• Experience working on clinical trials.
• Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
• Working knowledge of GCP/ICH guidelines.
• Knowledge of CDASH.
• Excellent written and verbal communication in English.
Preferred Experience
• Working knowledge of SDTM preferable.
• Experience in other EDC systems e.g., Veeva preferable.
• Basic custom functions programming knowledge preferred.
Advanced Level – see base level + relevant modifications below:
• Minimum of 5 years’ experience building EDC databases in support of clinical research.
• Technical EDC build experience in Medidata Rave implementing complex database builds.
• Demonstrated project management skills.
Preferred Experience • Advanced Custom functions programming knowledge.