Key Responsibilities::
Accountable for the end-to-end DS&M study related activities in terms of quality & delivery to plan which include:
o Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments
o Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation
o Interim and final cleaned database lock
o Archival of all DM documents in the eTMF
o 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 c...