Clinical Data Manager

Duties/Responsibilities
• Leads end-to-end data management activities on diverse scope projects
• Collaborate with Clinical Monitors/Clinical Study Managers/Clinical Research Associates/Biostatisticians to ensure all data is complete, timely, and accurate
• Enter data from research studies into the proper Clinical Data Management Systems
• Review data for quality and resolve discrepancies
• Assist in development, maintenance and management of case report forms/study worksheets to ensure consistency with the protocol and database
• Assist in development of the Study Requirements Specification
• Contribute to study-specific data management processes and documentation
• Generate data output and coordinate data output documentation
• Perform database validation under the guidance of the Clinical Database Developer or Data Management department leadership
• Contribute to the review and creation of processes related to Data Management
• Perform project in compliance with regulations
• Support routine internal audits of projects
• Ensure that the product/deliverable is the best it can be given time and budget constraints
• Function at a level that affords respect by internal team members
• Communicate project/team issues to Project Manager and/or Management
• Function as a productive project team member
• Keep project plan or study calendar updated
• Contribute to presentations, including preparation, assembling slides, and speaking
• Network with peers in the medical device industry
• Inform manager or marketing colleagues of potential opportunities

Qualifications/Skills
• Bachelor’s degree or equivalent experience in a related field, with a minimum of 3 years of relevant experience
• Fluency in English and Spanish

Technical Competencies
• Familiar with clinical trial processes
• Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC/REB personnel
• Technically conversant with respect to Clinical Data Management Systems