• Lead planning and operational feasibility assessments to ensure realistic and achievable trial timelines • Oversee trial set-up and ensure team alignment across functions including Statistics, Data Management, Medical Writing, and Site Monitoring • Support country allocation and feasibility processes; provide input to optimize site selection and trial readiness • Develop and implement trial-level engagement, recruitment, and risk mitigation plans, integrating patient and site feedback to enhance trial design and participant experience • Coordinate outsourcing of vendor services, supporting vendor identification, selection, and scope-of-work development • Partner with cross-functional teams to ensure readiness across all trial processes — clinical quality, safety monitoring, investigational product management, budgeting, and site support • Maintain oversight of global clinical trial conduct to ensure compliance with Good Clinical Practice (GCP), internal SOPs, and all applicable regulatory requirements • Oversee patient recruitment progress, risk mitigation, and budget tracking to ensure efficient delivery • Manage amendments to study documentation and related retraining as needed • Support ongoing communication and coordination across the clinical delivery network and stakeholders • Oversee data cleaning and trial closeout activities, ensuring timely and accurate data delivery