Position also requires: Good working knowledge of ICH, FDA, and GCP regulations and guidelinesStrong well-rounded technical skills including CDISC, STDM, MeDRAUnderstanding of data management technology, software languages and computer systemsSound knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operationsCompetency in multiple computer-based tools, in addition to software programs such as Word, PowerPoint, Excel, etc. Ability to work in and effectively contribute to cross-functional teams in face-to-face conversation, by telephone, and by emailExcellent verbal/written and interpersonal skillsAbility to create strong, collaborative working relationships and encourage creative solutions by effectively working through conflicts.