• Lead and contribute to the design of observational database analysis, including authoring protocols and analysis plans in support of RWE needs for the MedTech Cardiovascular franchise. • Lead the synthesis of evidence from observational database analyses with other evidence to inform medical decision-making, including authoring publications and presentations. • Work closely with colleagues within the department and across the larger cross-sector Epidemiology function, health economics and market access (HEMA) function, clinical function, and other Cardiovascular medical device functions. • Implement new approaches for working with “big data” in healthcare.

• Lead and contribute to the design of observational database analysis, including authoring protocols and analysis plans in support of RWE needs for the MedTech Cardiovascular franchise. • Lead the synthesis of evidence from observational database analyses with other evidence to inform medical decision-making, including authoring publications and presentations. • Work closely with colleagues within the department and across the larger cross-sector Epidemiology function, health economics and market access (HEMA) function, clinical function, and other Cardiovascular medical device functions. • Implement new approaches for working with “big data” in healthcare. • Some tasks may include data visualization, predictive analytics and machine learning algorithms.

• Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks. • Acts as an interdepartmental and client liaison for all DM study activities. • Produces project-specific status reports for management, Project Lead and/or clients on a regular basis. • Monitors and analyzes study metrics and escalates per the organization's risk management processes. • May participate in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required. • Assists with project forecasting of hours and identification of resource requirements. • Assists with the oversight of project budgets including identification of potential out of scope work and participation in the Contract Modification process. • Leads, high volume/highly complex studies. • Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality and budget. • Mentors junior level staff on all associated tasks within a study. • Assists with administrative and financial oversight for allocated projects. • Communicates with management regarding all data management activities within their studies.

• Acts as a liaison to the Project Lead and/or client as required and communicates with management regarding all data management (DM) activities within their studies • Develops and maintains data management project documentation files; performs independent reviews of data management deliverables following documented CDM guidelines • Develops and delivers study specific training for DM project staff • Produces project-specific status reports for management, Project Lead and/or clients on a regular basis • Monitors study metrics • May participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required • Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to Project Lead and management and assists with the Contract Modification process • Mentors junior level staff on all associated tasks within a study • Assists with the administrative and financial management of allocated projects • Performs all assigned data management activities independently and efficiently, with attention to quality