• Provides CDM leadership for one or more assigned projects or indications dependent on size and scale of the project • Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines • Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level • Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned programs, and projects • Communicates and negotiates effectively with all other Program level team members • Primary point of contact for Clinical Data Management (CDM) • Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology • Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards