Clinical Data Manager
New Jersey All, NJ
- Perform QC of CRO activities to include Query management, Data review, DM documentation such as edit checks, lock process, etc.
- Monitor progress of data management activities by CROs
- Participate in regular team meetings and provide input when appropriate
- Interact with CRAs, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
- Regularly reconcile the Safety database to the EDC database
- BS/BA degree or equivalent in a relevant scientific discipline with a minimum of three years experience as a data manager, or equivalent, in a pharmaceutical/CRO setting
- Advanced knowledge of Excel and MS Visual Basic required
- Knowledge of Medical Affairs helpful
- Experience in Hematology and or Oncology
- Proficient knowledge of EDC databases, preferably Medidata RAVE
- Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
- Proficiency in regulatory guidelines, agencies, GCP, etc.