AI-Enabled Global Study Manager

Role Summary

AI-Enabled Global Study Manager responsible for leading digital transformation across global clinical operations, driving smarter, faster, and more patient-centric trials. Lead innovation in clinical study processes, oversee cross-functional teams, and ensure alignment with GCP and internal SOPs.

Responsibilities

• Lead the cross-functional study team and oversee global study processes including protocol development, enrollment, data collection, and budget/timeline management.
• Identify and pilot AI and digital solutions to improve study efficiency, quality, and patient experience.
• Rotate through key roles within the clinical science organization to assess firsthand opportunities for transformation.
• Develop and propose digital transformation plans to address common challenges in clinical operations.
• Collaborate with medical leads, data managers, statisticians, regulatory affairs, and other stakeholders to ensure study success.
• Ensure compliance with GCP and internal SOPs, and recommend updates to processes where needed.
• Select, implement, and oversee vendors supporting AI-enabled solutions.
• Promote a culture of continuous improvement and innovation in clinical trial methodologies.

Qualifications

• Over 6 years of demonstrated experience rooted in scientific, engineering, or data science disciplines, with practical expertise in applying digital technologies to clinical development.
• Proven ability to act as a change agent—driven to identify transformation opportunities and champion innovative, forward-thinking solutions.
• Hands-on experience leading and supporting clinical trials, with a deep understanding of the complexities involved in global study operations.
• Skilled in navigating cross-functional teams and influencing diverse stakeholders through clear, compelling, and strategic communication.
• Strong capabilities in evaluating business cases for digital solutions, including ROI analysis and structured go/no-go decision-making frameworks.
• Bachelor’s degree required; Master’s degree preferred in a relevant field

Skills

• Digital transformation in clinical operations
• AI and digital solution evaluation and implementation
• Cross-functional leadership and stakeholder management
• GCP compliance and SOP adherence
• Business case analysis and ROI assessment

Education

• Bachelor’s degree required; Master’s degree preferred in a relevant field

Additional Requirements

• Location: Morristown, NJ; Cambridge, MA
• Travel: Not specified in the description