* Lead the planning, initiation, execution, and close-out activities for assigned clinical trials, working closely with internal and external stakeholders.
* Develop and manage trial budgets, timelines, and resources, ensuring efficient and effective trial progress.
* Oversee the selection, qualification, and management of contract research organizations (CROs) and other external vendors, ensuring their performance meets trial objectives and quality standards.
* Ensure adherence to all applicable regulatory requirements (e.g., FDA, NMPA), ICH GCP guidelines, and Lilly SOPs throughout the trial lifecycle.
* Manage trial-related documentation, including protocols, informed consent forms, monitoring plans, and clinical study reports.
* Facilitate effective communication and collaboration within the clinical trial team, including clinical scientists, medical monitors, biostatisticians, data managers, and regulatory affairs personnel.
* Monitor trial progress, identify potential risks, and implement mitigation strategies to ensure successful trial completion.
* Participate in the development and review of clinical study reports, publications, and presentations.
* Contribute to the continuous improvement of clinical trial processes and operational excellence.
* May involve direct supervision or mentorship of junior clinical trial staff.