AI-Enabled Global Study Data Leader

Role Summary

AI-Enabled Global Study Data Leader responsible for end-to-end data management digital transformation in clinical studies. Leads digital change across the organization, developing transformation plans, and implementing digital solutions to improve data management and study efficiency. Requires strong leadership, change management skills, and experience assessing business cases and ROI for digital initiatives.

Responsibilities

• Influences and leads critical elements of the clinical data management digital transformation of clinical operations.
• Serve as a catalyst for digital change within the organization and offer expert perspectives on potential solutions and changes for the ways of working.
• Develop a transformation plan to solve common challenges or develop / propose digital solutions for data management.
• Contribute to accelerate the development of new drugs and medical devices through clinical trials.
• Identify new data management digital AI opportunities, in close collaboration with digital.
• Be the Data Management leader in the cross-functional study team and oversee study processes at a global level, including protocols, data collection methods, risk-based data management processes and timelines.
• Explore new ways of data collection (eSource access, patient devices, etc.).
• Work with cross-functional teams including medical leads, global study lead, statisticians, clinical supply managers, regulatory affairs specialists, etc.
• Ensure compliance with GCP, ICH, internal SOPs; propose updates and improvements to processes as relevant.
• Pilot and implement digital / AI solutions to improve study efficiency and data quality.
• Maintain awareness of industry trends, assess opportunities for innovative digital solutions, prepare business cases and proposals to drive value.
• Drive implementation of innovative data management methodologies and technologies.
• Foster a culture of continuous improvement and learning.
• Demonstrate leadership in overseeing studies from setup to closure, ensuring smooth and efficient operations.
• Define and monitor progress of studies and innovative solutions, identify risks and issues, implement corrective actions and oversight timelines.
• Implement new and innovative methods of communications and updates.
• Lead the selection, implementation, and oversight of new vendors to support AI solutions.

Qualifications

• Required: Bachelor‚Äôs degree; Master preferred. Life sciences or health information management field is desirable. Clinical Data Management in pharma/healthcare is a plus.
• Experience: 6+ years in clinical data management and/or clinical data science with direct experience assessing and implementing digital technologies in clinical development.
• Knowledge: Deep knowledge of clinical data science, digital tools, AI and Generative AI tools applicable to Data Management.
• Project management: Ability to manage cross-functional projects with intermediate project, risk, and vendor management skills; compliance and quality standards.

Skills

• Digital transformation leadership
• Clinical data management and data science
• AI and digital tools for data management
• Regulatory compliance (GCP, ICH) and SOPs
• Stakeholder collaboration across medical, statistical, regulatory, and operations teams
• Vendor selection and management
• Change management and continuous improvement

Education

• Bachelor‚Äôs degree required; Master‚Äôs preferred (life sciences or health information management preferred).

Additional Requirements

• Location: Morristown, NJ; Cambridge, MA