Otis Somerset Williams

Adept Clinical Pharmacist with a proven track record at the College of Medicine and Allied Health Sciences, University of Sierra Leone, showcasing expertise in pharmacology and vaccine accountability. Demonstrated excellence in enhancing medication therapy management and fostering interdisciplinary collaborations. Renowned for meticulous attention to detail and exceptional communication skills, contributing significantly to pioneering health surveys and clinical trials.

• Dr. Eugene B.S. Conteh, Acting Head of Department Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, College of Medicine and Allied Health Sciences, University of Sierra Leone, +232-78-530-357, eugene.conteh@usl.edu.sl
• Dr. Michael M. Kamara, Research Fellow and Clinical Trial Manager, PREVAC-UP, Department of Clinical Research, Faculty of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, Keppel Street, London, England, WCE17HT, +232-78-002-625, Michael.Kamara@lshtm.ac.uk

I am ICH-GCP trained and have significant experience in preparing and dispensing investigational medicinal products(IMPs) and drugs, vaccine accountability, and cold chain management in clinical trials. For example, in my previous role as the clinical trial pharmacist, I was responsible for the day-to-day and overall management of IMPs, medicines (for trial participants and staff), and cold chain, performing and recording daily temperatures checks, quality control checks, and ensuring data accuracy and completeness of vaccine request forms from trial physicians. I am knowledgeable about data protection and participant confidentiality.

Furthermore, I have outstanding organizational and time management abilities, and I have demonstrated the capacity to work both independently and collaboratively as part of a multidisciplinary research team. For instance, in November 2022, our clinical trial site was notified of a US FDA ( Food and Drug Administration) inspection which was scheduled to be held in January 2023. This was the first FDA inspection of the trial site and the country. The trial team was under huge pressure to prepare for the inspection while also undertaking other ongoing trial activities. As the pharmacist of the trial site, I organized a meeting with my team and mapped out a clear and concise inspection plan to robustly review all the essential documents in the pharmacy section of the trial master file (TMF), vaccine dispensing log, and all vaccine reconciliation documentation. The inspection plan was shared with the Principal Investigator (PI), trial manager, sub-investigator, and other members of the trial team for their review and comments. Working closely with other team members, we constituted an FDA inspection preparedness team which was responsible for all the necessary preparation (including logistics) for the inspection. I organized daily debriefing meetings with my team to ensure that the daily inspection preparation tasks were completed, and I escalated challenging issues to the PI and trial manager. Within 6-8 weeks of intense preparation, I was able to lead the team and complete the needed preparation. On the day of the FDA inspection, I was one of the staff interviewed by the FDA inspectors and I responded appropriately to all the questions asked. In the end, we passed the FDA inspection with no major findings. This was a major finding. This was a major achievement that led to the successful licensure (by the US FDA) of one of our trial vaccines as prophylaxis for Ebola in children. While this experience demonstrates my ability to work as part of a team, it also shows my leadership and time management skills