MA/ Medical Advisor:泌尿器癌専門医、Oncology-Urology


部署 MA
仕事内容 Medical Monitoring:
 Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.
 Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
 May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
 May provide therapeutic area/indication training for the project clinical team.
 Attends and may present at Investigator Meetings.
 Performs review and clarification of trial-related Adverse Events (AEs).
 May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
 May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
 May perform medical review of adverse event coding.
 Performs review of the Clinical Study Report (CSR) and patient narratives.
 Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
 Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.



必須  MD licence
 Clinical Experience in Oncology-Urology in Japan
 Current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
 Good communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
 Ability to establish and maintain effective working relationships with coworkers, managers and clients.
 Attention to details, ability to provide advice on multiple assignments and flexibility.


待遇 【給与】経験・能力・資格等考慮し、弊社規程に則して決定します。
【昇給】 年1回(7月)
【賞与】 年2回(6月・12月)、業績賞与(3月)
【諸手当】 時間外手当、通勤手当、外勤手当(CRA職等)

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