|職種名||【臨床開発 Project Manager】|
|仕事内容||・Participates in the site qualification and initiation process, including progress monitoring activities with site personnel.
・Develop/maintain project timeline, manage study budget, negotiate and execute site contract,and payment plan
・Assist site with development, approval, and distribution of study-related documents including Case Report Forms(CRF's),study protocols, study manuals, and other study tools to Investigational sites and review committees.
・Prepares and participates in presentation of protocols and other study conduct requirements at study initiations at investigational sites when needed.
・Assists in planning, preparing, and distributing materials for investigator and coordinator meetings,and for study-related training.
・Tracks and reports progress of studies including patient enrollment /screening, data collection,adverse event documentation etc.
・Communicate with HQ clinical team to prepare study protocols, CRFs and other necessary documents
|応募資格||・Bachelor's-level degree required.
・Experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry required.
・Experience in preparation/management of clinical documents required.
・Willingness to travel.
・Excellent interpersonal and organizational skills.
・Detail oriented and good problem solving ability.
・Ability to work on cross-functional teams and with multiple projects.
・Excellent computer skills.
・Fluent English communication skills(especially in reading/writing).
・Degree in science/health related field(e.g, Biology, Nursing, Biomedical or Veterinary Sciences) preferred.
・5+years of clinical monitoring experience preferred. Project management experience preferred
・Medical degree & post doctoral fellowship preferred
|勤務時間||09:00 ～ 17:30|