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Managing CDM Team Growth

Managing CDM Team Growth. Kelly Ritch, M.S. Assistant Director Department of Clinical Data Management Rho, Inc. 100 Eastowne Drive Chapel Hill, NC 27713. Past Everyone did everything Data processed as completed subjects Financially closely tied to client Large trials meant large CROs.

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Managing CDM Team Growth

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  1. Managing CDM Team Growth Kelly Ritch, M.S. Assistant Director Department of Clinical Data Management Rho, Inc. 100 Eastowne Drive Chapel Hill, NC 27713

  2. Past Everyone did everything Data processed as completed subjects Financially closely tied to client Large trials meant large CROs CDM Evolution

  3. Why evolve? • Desire to win more & bigger trials • Too much pressure on a small number of people to be perfect. Easier when studies were complete-later slides discuss never real time demands on DM. Requires group working interdependently, checks and balances. • More clients means more financial stability, more compartmentalized can handle more work if it runs in two.

  4. Clinical Data Leadership vs. Clinical Data Management • Improves the incoming information come in process rather than managing an existing process end point. • Improves the data rather than just keeping the data status of the information we are holding • Creates proactive/partnership role rather than reactive/passive role

  5. Are these the “right” m&m’s?

  6. Why evolve? Revisited • Meet demand for high quality • Interaction required with diverse personnel • Pieces & Parts • Increasing scopes require flexibility • Decisions save $$ 6.Future Relationship

  7. Past Everyone did everything Data processed as completed subjects Financially closely tied to client Large trials meant large CROs Present & Future Each person has a roles Data is processed in small pieces Diversity within and between clients Large trials done by well run team CDM Evolution

  8. Creating the CDL Team Roles • Document Management • Database Development & Setup • Development of logic checks, program & report specs • Query Problem-solving • Organizing study materials • Quality control • Final Decision Maker/Communicator

  9. Skills Communication Meticulous review & organization Terminology & therapeutic familiarity Aptitude for logic & problem-solving Ability to distribute Final decision responsibility Backgrounds Clinical Math English Customer Service Sales Project Management History Creating the CDL team

  10. Remember this… • Know the roles you need. • Know what skills are necessary for each role • Need well running teams in order to meet future real-time demands

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