What are the responsibilities and job description for the Clinical Data Manager position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Serves as primary DM contact for assigned studies, including representation on project teams and working with CROs performing data management tasks for assigned study.
- Monitors data clean-up process performed by CROs 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 Client's SOPs.
- Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects.
- Designs and modifies CRF.
- Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities.
Requirements :
