Sharing a Vision to Drive Healthcare Forward
Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources.
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Provide timely status updates including issues & risks to DM and DMLs as needed
Act as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigations
May communicate with the vendors to resolve reconciliation issues.
Provide input to Study set up activities including but not limited to creation of DVRs
Create and/or provide inputs to Data Management documents (e.g. eCRF completion guidelines, etc.).
Review and provide inputs to Data Management documents (e.g. IRP, DMP, etc.)
Assign work to allocated CDAs on a trial. Coordinate work of CDAs assigned to a study working closely with the Global Data Manager to understand priorities and timelines.
Assist the Data Management Leader in TMF compliance reviews.
Train and mentor CDA staff
May serve as an SME and participate in SME forums
May act as delegate for Data Manager, as needed
Education and Experience Guidelines:
Bachelor’s degree in a Health or Science discipline with experience in clinical research.
Experience CDA ADVANCED level: >3 year of experience Data Management experience
Data Management experience and experience working on a clinical trial mandatory.
Rave experience mandatory
Experience working in highly diverse teams within clinical research; cross-functional, global, multi- regional.
Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) for Advanced CDA.
Knowledge of technology platforms and systems to capture and process data
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