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Digital Data Flow

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Clinical Data Manager Persona Toolkit

TransCelerate has created several persona-specific toolkits to support change management and transformational activities within sponsor organizations.

Please note, job titles, roles, & responsibilities can and will vary, often significantly, across companies. The persona toolkits seek to outline some discrete tasks commonly performed by specific roles as part of that persona and explain how the DDF initiative will likely impact these tasks. The toolkits do not seek to address all tasks performed by personas nor does it seek to dictate or suggest to the persona how relevant tasks must or should be performed, as this will vary greatly across companies.

This toolkit is a change resource for Clinical Data Manager that describes how the DDF initiative will likely impact some discrete tasks commonly performed by this persona.

Below table includes a link to the full toolkit (eBook), as well as each individual section of the toolkit so each component can be accessed separately.

Content Description
[Full Toolkit] DDF Persona Toolkit for Clinical Data Manager (DM) The objective is to help clinical data managers understand and better prepare for how to adapt their role and responsibilities to new ways of working within an automated and digitalized study lifecycle.
DDF Initiative Overview This overview provides key information pertaining to the overall Digital Data Flow (DDF) Initiative.
Toolkit Overview (DM) This describes the toolkit purpose, components, and ways to use it.
Persona Profile Card (DM) This describes the profile for a typical Clinical Data Manager role as described in this toolkit. It can be utilized to help Clinical Data Manager understand the benefits and value of digitalization of data flow within the context of protocol authoring.
Persona Change Impacts (DM) This articulates potential impacts to a Clinical Data Manager role comparing the current state (As-Is) to the anticipated future state (To-Be).
Persona Day in the Life (DM) An illustrative flow of “What could a work-day look like with the application of DDF?”