Pharm. MSc. Ahmet Ozan Özgen
Clinical Research Specialist
Custom-tailored solutions to meet and satisfy your needs.
Custom-tailored solutions to meet and satisfy your needs.
As a Clinical Research Specialist, currently in a pharmaceutical CDMO, I bring a versatile approach to the field, with a strong data management and interpretation. My background in academic research equips me with a scholarly perspective, thereby amplifying the credibility and impact of the projects. I am always eager to expand my knowledge and skills.
I graduated from Istanbul Medipol University Faculty of Pharmacy. 9 months of mandatory internship were included in the University's education program (throughout 5 years). I have worked 3 months in a university hospital as a clinical pharmacist, 5 months in retail pharmacies and a month in the marketing department of a pharmaceutical company. I took part as the 2nd term delegate of the Istanbul Chamber of Pharmacists Youth Council, and after graduation, I continued to contribute to the Assistant Pharmacists & Youth Council commissions.
I am currently working as a clinical research specialist. In my role, I oversee the coordination of preclinical, clinical, and bioequivalence studies, ensuring strict compliance with research and development timelines and product launches. I author expert reports and manage preclinical/clinical CTD modules for projects across over 50 countries. Additionally, I manage responses to queries and deficiencies from domestic and international regulatory bodies.
I am currently studying for my PhD in Gene and Cell Therapy, and focused on bioinformatics to specialize in data science and programming languages.
Examples are listed below for your review and a better understanding. Also before starting, you can play this game 😸.
Services
I frequently organize and report data coming from foreign pharmaceutical markets with demand forcasting, for supply chain management, using R and Python.
I have been interested in advanced therapeutics since my undergraduate education. This interest has propelled me to persistently pursue further education in this field, deepening my understanding and fueling my passion for innovative healthcare solutions.
It is critical to foster relationships with CROs, vendors and clinical sites while working closely with investigators. My business development expertise has been instrumental in expanding our reach and impact in this domain. I routinely assess our partners' performance and strategize to boost research results. Moreover, I proactively scout foreign markets to identify potential alliances, fostering sustainable project management even when bound to existing partners.
With extensive experience in preclinical and clinical research, I have contributed to the development and validation of generics and biosimilars, ensuring their safety, efficacy while maintaining projects' credibility.
References
Dr. Devrim is my supervisor in Akdeniz University. We are working together in studies related to in-silico research, and pharmacoeconomics. She is one of the KOLs in Turkiye for biosimilars, their development and registration processes.
I have met Dr. Aydın through the Clinical Research Association's (Turkiye) several events and had a chance to benefit from his experiences regarding GCP guidelines and international regulations (EMA). He is a pioneer in organizing clinical trials in Turkey.
Ms Majid was my peer while she was working in Briogene (a subsidiary of Getz Healthcare). We have coordinated our operation for IVD in Pakistan with her for two years.
