Clinical Data Management: Creates and maintains study data management documents according to instructions (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User’s Guide, EDC Training and Certification Documents). Designs and/or develops electronic Case Report Forms (e. CR - Fs). Systems Specifications Development: Develop requirements for EDC system and databases employing complex validation rules, and edit checks. Technical Support: Assist with systems testing, configuration and usage questions. Collaboration: Work with system developers to support development and implementation. Basic Qualifications. A BA/ BS in science or related field (medical or computer science preferred) with 8 or more years of relevant experience or an MA/ MS in science or related field (medical or computer science preferred) or other advanced degree with 2-4 years of relevant experience. Preferred Qualifications. Industry Knowledge: Experience with clinical research, specifically data collection, management, and standards. Technical Proficiency: Knowledge of MS office products, Box and expertise with Red. Cap Cloud, Medidata Rave or similar EDC systems.for reporting. Communication: Able to communicate clearly and effectively both written and verbal. Strong interpersonal skills and ability to work effectively and collaboratively within a team environment. Autonomy: Proven ability to work independently. Compliance: Excellent knowledge of CDISC standards, FDA regulations, ICH guidelines, and GCPs – and their application to clinical trials.