Sr Clinical Data Analyst

The Sr. Clinical Data Analyst is responsible for assisting Clinical Data Managers and ensuring that data management services (clinical data and data structure) are delivered in a complete, consistent, accurate and high quality manner for assigned Abiomed Clinical Study(ies).  The Sr. Clinical Data Analyst works closely with Senior Clinical Data Manager and Clinical Program Manager(s), and Clinical Research Associates, to execute the trial.  She/he may need to engage and work closely with CROs and Vendors that execute the data management and Core Lab services.

Primary Duties and Responsibilities:

• Works independently to provide data review listings as requested by clinical and medical teams
• Reviews data and manages queries based on programmed edit checks and Data Management Plan
• Reviews data listings to clean data and issue queries if needed
• Performs external vendor (i.e. Core Labs) data processing and external vendor data reconciliation
• Performs EDC User Acceptance Testing (UAT)
• Contributes to preparation and maintenance of data management documents

• Works with clinical programming team/vendor to achieve eCRF development
• Supports and provides cross-functional collaboration and communications to increase quality of data management deliverables
• Provides data review metrics, query metrics and other metrics as requested

• Reviews, analyzes, validates and maintains clinical trial data ensuring consistency, integrity and accuracy
• Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others to meet project deliverables and timelines
• Utilizes reports to track study progress and ensure timeliness and quality expectations are met
• Develops, tracks, analyze and reports, as applicable, on data management performance metrics
• Participates in the review of Clinical research documents (e.g. Protocols, Safety Monitoring Plans, Data Management Plans, Communication Plans).
• Ensures the clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock

• Identifies potential project risks and drafts mitigation strategies with the internal project team to proactively address issues
  • Maintains a consistent, manageable workflow for DM project team by monitoring enrollment information and communicating with project team to actively influence data collection
  • Capable of handling studies that are complex in scope and volume