Details of person submitting   
Name Maria Craze
Organisation Merck Sharpe & Dohme Inc (MSD)
Email maria_chicco@merck.com
   
Details of abstract   
Title of abstract  Evolution of the Data Manager: Past , present and the GREAT FUTURE to Come!
Abstract 

The days of the traditional data manager of the past, manually entering data from a paper CRF into a database and passing that data along for another data manager to manually clean, are LONG GONE. Today, most see the data manager as a processor of the clinical data in an EDC system; turning clinical requirements into specifications, verifying edit checks, running exception reports and listings, etc. to clean the data and manually writing queries to site staff. Then stop and repeat. But I pose that even this role of the data manager is becoming obsolete and is the new definition of the “past” when describing a data manager. The role of the data manager is evolving, and we can catch up and stay ahead, or get lost in the past. Data Managers will have to think more intelligently and handle more complex scenarios as automation takes care of the repeatable and predictable. The Future data manager must be highly skilled in end-to end study design, signal detection, risk management, problem solving and team leadership as well as have a high tolerance for the ambiguous and live and breathe adaptability. We must recruit data managers for their POTENTIAL in these areas, cultivate that potential and develop the data managers for the future. Traditional activity-based learning plans and sequential development plans just do not evolve fast enough. In this session, the panel of CDM experts will provide their perspectives on the past, present and most importantly the future of the data manager. This must be a CONTINUAL EVOLUTION and never again a once and done catch up exercise. Just as the science and technology of clinical trials is evolving so must the data manager.

 

First learning objective Educate the audience on CDM as a evolutionary role
Second learning objective help CDM managers/leaders in the audience to think about how to evolve their DMs for the future
Third learning objective Address audience questions and concerns around the role of the DM of the future
   
Presenter Details  
Name  Maria Craze 
Organisation Merck Sharp & Dhome Inc. (MSD)
Job title Executive Director- Global Data Operations