Manager Data Management
Manager Data Management
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Job Description
Accountable for the end-to-end DS&M study related activities in terms of quality & delivery to plan which include:
Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments
Defining and executing the Data Management Strategy including data ingestion cleaning & reconciliation
Interim and final cleaned database lock
Archival of all DM documents in the eTMF
Archival of the study database and provision of clinical data to the study site
Accountable for one or several complex studies and has the ability and experience to manage the delivery of any type of study (different therapeutic areas complex/unusual early phase setting new/unusual indication pivotal/Phase III and efficacy studies clinical as well as epidemiology studies)
For an in-house study leads the day-to-day DS&M operational study related activities acts as a member of the study core team and is the single point of contact for all the DM study related activities & matters
For a study outsourced through a DM Functional Service Provider (FSP) or Full Services Outsourcing (FSO) conducts & documents sponsor oversight of the end-to-end FSP/FSO study related activities and ensures training on the protocol to the FSP resources working on the study
Provides DM operational input into the study design the protocol study planning study documents including the study risk register
Remote Work :
No
Employment Type
Full Time
