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, driving innovation and efficiency across the clinical development value chain. Leads digital data technologies, ROI evaluation, and change management to deliver transformative approaches for patients.

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 accelerated 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 collection quality.
• Maintain current awareness of industry trends, assess opportunities for innovative digital solutions, and prepare business cases to drive value.
• Drive the implementation of innovative data management methodologies and technologies.
• Foster a culture of continuous improvement and learning.
• Demonstrate leadership in overseeing the conduct and closure of clinical studies, ensuring smooth and efficient execution.
• Define and monitor study progress and innovative solutions, identify risks and issues, and implement corrective measures and 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‚Äôs preferred, ideally in life sciences or health information management. Clinical Data Management in pharma/healthcare a significant plus.
• Experience: 6+ years in clinical data management and/or clinical data science with proven experience assessing and implementing digital technologies in clinical development.
• Deep knowledge in clinical data science, digital tools, AI and Generative AI tools applicable to Data Management.
• Ability to manage cross-functional projects with intermediate project, risk, and vendor management skills to deliver compliant and quality results.

Skills

• Digital transformation and data management leadership
• Regulatory compliance (GCP, ICH) and SOP governance
• AI/GenAI solutions in clinical data management
• Vendor management and cross-functional collaboration
• Change management and continuous improvement
• Business case development and ROI assessment

Education

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