Senior Clinical Data Manager

• Create, review and approve all data management study-related documents
• Perform and manage all data cleaning activities, including processing queries, performing ongoing data review, and orchestrating scheduled cross-functional data review/reconciliation, identifying issues, data trends and tracking them through resolution
• Perform and manage all database build activities, database validation and review and execution of User Acceptance Testing (UAT)
• Represent Data Management in 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 manager any requested out of scope activities
• Work with outside vendors (such as safety laboratories, cardiac laboratories) to develop data transfer documents and perform regular data reconciliation with the clinical database
• Assist the DM oversight role/manager in monitoring timelines and managing resources to meet timelines
• Identify inconsistencies and inefficiencies in data management processes and recommend solutions
• Perform other duties, as needed
• Medidata Rave EDC, Medrio eClinical and Clario EDC experience
• 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) .

Requirements:

• 8+ years of Data Management experience
• Bachelor's Degree in a Science and/or Technical-related field
• Microsoft Excel proficient
• Solid problem solving and time management skills
• Great interpersonal skills
• Excellent communication skills (written and verbal)
• Strong attention to detail
• Highly organized
• Previous CRO experience
• Ability to program in SQL or SAS