Clinical Data Manager
- Demonstrated subject matter expertise in all aspects of the Data Management discipline. Ability to support multiple studies concurrently with minimal oversight by function manger.
- Advocates the DM position within study team meetings and coaches vendor staff supporting DM work.
- May act as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, eCOA, data visualization, etc.
- May contribute to subject matter expertise to support process improvement initiatives.
- Oversees multiple DM vendors and provides training as necessary
- Participates in study level budget review activities for individual studies
- Provides feedback and suggestions for improvement in DM vendor discussions.
- Uses metrics and key performance indicators to monitor vendor performance.
- Performs vendor oversight activities across multiple studies. Proactively shares and provides suggestions on how to improve vendor oversight with functional manager.
- Documents any process related deviations and communicates to functional manager.
- May attend or participate in key industry conferences or related initiatives.
- Strong cross-functional understanding on the impact of data management processes to other stakeholders.
- Has a good understanding of regulatory guidelines and issues (i.e. ICH GCP), and understands the connection to DM deliverables.
- Develops a strong partnership with vendor lead data managers to ensure program level deliverables are on track.
- Leads the data review meetings with Medical, Clinical, Biostats,and Programming in support of key reporting events or database lock plans.