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.