Job DescriptionOverseeing and developing clinical projects including component studies
Providing not only strategic and scientific input but also development support for clinical plans and individual study protocols
Developing case report forms, performing medical monitoring, liaising with investigators and site personnel
Performing preliminary and exploratory data analyses clinical trials
Authoring clinical study reports; providing input on publication materials
Participating in the development of clinical operating guides, maintenance of secure study files and reviewing results of these evaluations with appropriate management prior to implementation
Lead and support regulatory submission documents such as briefing documents and relevant clinical modules in J-CTD
Participate and represent Japan at global Compound development Team and provide proactive scientific input related to Japan specific needs and/or requirements.
Collaborate cross-functionally with other R&D functions both at local and global level for clinical projects related to Japan development.
CTD & Protocol experience
Business level English