Roman Young

Served as the first Cell and Gene Therapy Logistics Manager, acting as the primary point of contact for all logistical issues related to specimen shipment and final drug product. Developed and implemented study tools including Logistics Management Plan, Process Map, and Cell Therapy Manual, ensuring comprehensive understanding and management of new documents for the Trial Master File (TMF).

Managed all activities related to the implementation and execution of clinical studies, working with Project Managers to define program targets and ensure work was documented within contracted scope. Developed and implemented Clinical Monitoring Plans, coordinating remote review of clinical data within EDC systems. Served as a CRA mentor, performing accompanied field assessment visits and ensuring

Participated in investigator recruitment and performed site evaluation visits, assessing site capabilities for successful clinical study management. Provided clinical and technical support to CRAs and administrative staff, completing project activities for Phase I-IV clinical research studies. Collaborated with ISS and site staff to obtain regulatory approval and trained site staff on EDC systems.

Monitored clinical studies with a focus on data integrity and patient safety, adhering to country-specific regulations. Planned day-to-day monitoring activities and set site priorities, specializing in Oncology/Rare Disease trials and DEA Scheduled Drugs Logistics for Eating Disorder Trials. Responsible for submitting regulatory packages to ethics committees and competent authorities.

Completed project activities related to monitoring functions for Phase I-IV clinical research studies, developing a thorough understanding of drug development and GCP. Provided clinical and technical support to CRAs and administrative staff, ensuring the integrity of clinical data through adherence to regulatory guidelines and SOPs. Maintained timely and effective communication with team members a

Majored in Psychology with a focus on Pharmacology and minored in Medical Geography with an emphasis on Epidemiology. This interdisciplinary study provided a strong foundation in understanding the biological and geographical aspects of health and disease.