Manager, Clinical Data Scientist, Clinical Data Sciences

Overview

Serve as Clinical Data Scientist for one or more clinical trials, representing Clinical Data and Information Sciences (CDIS) at the study team level and accountable for all CDIS deliverables, data quality and inspection readiness.

What you'll do

• Coordinate all CDIS deliverables associated with a clinical trial and ensure their quality and timeliness.
• Select and apply data acquisition standards, prepare the Data Management Plan, select quality risk indicators and perform third-party study data due diligence.
• Serve as a core study team member, driving operational excellence with cross-functional partners through application of CDIS best practices.
• Act as technical resource on how to best collect, process, consume and report clinical trial data.
• Partner with Research/Business Units, external data/service providers and internal CDIS staff to deliver high-quality data management.
• Proactively drive quality and efficiency to meet study and asset timelines and milestones.
• Ensure work is in accordance with applicable SOPs, regulations, standards, GCDMPs and ALCOA principles.
• Ensure study-specific CDIS documents in the Trial Master File (TMF) are of high quality and filed contemporaneously.
• Work with Asset Leads to establish strategy, timelines and adequate resourcing of the study.
• Provide leadership, direction and oversight to CDIS resources and Data Managers working on the clinical trial(s).

Details

• Work location assignment: On Premise.