Description
- Serves as primary DM contact for assigned studies, including representation on project teams and working with CRO's performing data management tasks for assigned study- Coordinates, leads and performs clinical data management activities for assigned studies in accordance with Regeneron's SOP's and policies and practices including, not limited to:
- Monitors data clean-up process performed by CRO's from study start-up through data archiving
- Provides data for analysis
- Coordinates activities including: medical coding; data validation checks and database snapshot
- Prepares and distributes project status reports to project team and management
- Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with Regeneron SOP's
- Creates and maintains project documentation, including, but not limited to, Data Management Plan, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRFs.
- Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities
- Contributes to upkeep Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization
- Works with study team and coordinates all data management functions. Manages coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures
- Adheres to procedures surrounding retention of data, records, and information for clinical studies
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