Description
Qualifications-Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field: 6 years experience, or BS/BA degree with 4 years experience, or MS degree with 2 years experience.
-Minimum 2 years experience within a clinical data management organization, preferably within medium-large pharma or CRO.
-Knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials
-Knowledge of Research & Development and an understanding of regulatory guidelines/requirements related to R & D (e.g., ICH, GCP, safety reporting)
-Working knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.).
-Working knowledge of EDC (preferably Phase Forward InForm) would be highly desirable.
-Competencies and skills in the following: cross functional relationships, communication, decision making, execution/results/process improvement, customer satisfaction
-Ability to effectively interact with and influence others without direct reporting relationships
-Ability to multi-task and prioritize
-Planning, organizational, and project management skills
-Document writing skills
-Attention to detail with high quality outputs
-Proactive and critical evaluation of varied and multiple aspects of trial implementation to ensure timely completion and with requisite quality
-Ability to meet challenging milestones
-Analytical and problem solving skills
-Computer skills (word processing, spreadsheets, graphics, PowerPoint
To find out more about Real please visit www.realstaffing.com