Taking a broader view to support you
My name is Jiwon Kim and I am a Project Manager in the Global Project Management (GPM) Department at Linical`s Tokyo office. I wish to take a moment to introduce myself and present my experiences.
I am originally from Korea but have been living in Tokyo since I joined Linical in 2012. I have been working as a CRA, Monitoring Leader and PM in various indications, including oncology, CNS and musculoskeletal diseases. Most of my experience in Multi-regional clinical trials (MRCTs) is in Japan-led studies. I believe that I know what Japanese pharmaceutical companies want to know and also what their concerns and considerations may be when conducting overseas clinical trials out of Japan. I also have experience of conducting clinical trials within Japan and I can therefore advise on running clinical studies in Japan from a non-native perspective. As one of a number of experienced Project Managers who now live in Japan but have come from other countries, there are some significant advantages that we can offer our clients.
Below are some examples: GPM members are composed of Japanese and non-Japanese members and we all know the Japanese clinical trial environment well having run numerous local Japan studies. Our team understands the unique environment of Japanese trials which means that we can make suggestions, propose solutions and provide explanations regarding any concerns or doubts that our clients, who have no experience of Japanese local clinical trials, may have.
GPM members can propose the most overall efficient strategies. Since colleagues of various nationalities are located in both Tokyo and Osaka, we can easily discuss with colleagues from e.g. Taiwan or Europe in order to map out strategies to propose the shortest scenario to NDA approval in different regions.
Various nationalities in both Tokyo and Osaka
GPM members can easily communicate with not only Japanese clients but also local staff within each country. Our members are located in Japan as Project Manager’s (PM’s) so that our clients can communicate easily and in a timely manner with them. After discussions with our clients, the PM can confidently deliver the sponsor`s perspective and feedback to each region in a timely and accurate manner. This communication is enhanced by the language ability of our team, which offers a huge advantage since all members are proficient in Japanese, English and, obviously, their Native language.
We are proud of delivering successful projects and I hope that the above advantages and my experience give you confidence on considering Linical as your true Clinical Development partner.