Clinical Data Manager

Responsibilities:

• Provide data management expertise and support to internal project teams, clients, and Clinical Research Organizations (CROs)
• Plan, perform and oversee development of specifications for eCRFs/CRF, edit checks, electronic data handling, manual review, and execution of User Acceptance Testing
• Conduct and orchestrate scheduled cross-functional data review, identification of issues and track through resolution
• Participate in innovation and implementation of new technologies resulting in data management process improvements
• Ensure adherence to quality control procedures for data management activities
• Write appropriate Standard Operating Procedures (SOPs)/training guidelines and oversee revisions / updates to current SOPs/training guidelines for data management activities
• Facilitate and oversight of internal study team, client and CRO meetings
• Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to Director any requested out of scope activities

Requirements:

• 2 years of Data Management experience; or 1+ year of Data Management experience with a bachelor's degree; or, 1+ year of Data Management experience with a Bachelor's Degree
• 1+ year of experience in the Pharmaceutical/Biotechnology industry or CRO environment
• 1+ year of experience supervising Clinical Data Managers and/or team activities
• Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes
• Good knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonization (ICH) guidelines and Good Clinical Practices (GCPs), including regulatory requirements for the conduct of Clinical Development programs
• Solid analytical and research skills
• Great interpersonal skills
• Excellent communication skills (written and verbal)
• Strong attention to detail