外資系大手CRO　Associate Medical Director/Medical Director

資格・要件

【必須条件】
・医学位（MD）を有する方
・医師免許を有する方
・病院での実務経験が2年以上あること（神経内科、腫瘍内科、一般内科のいずれかの専門分野の経験があれば尚可）
・日本およびリージョナル/グローバル環境の両方で業務ができること
・日本語および英語に堪能であること

【歓迎条件】
・規制当局または製薬会社での業務経験

職務内容

■Responsibilities: Project Related Medical/Safety Management:

◇Minimize potential risk and clients by managing medical aspects of contracted tasks. This includes, but is not limited to, medical monitoring of all safety variables (AE, laboratory abnormalities, changes in patient medical status as well as inclusion/exclusion criteria, evaluation prescribed concomitant medication for protocol restrictions and unblinding requests). Scope of work also includes discussion internally with medical monitors in Japan, APAC and global and project team colleagues internally, as well as with principal investigators and clients of all medical issues during the course of a study by proper medical judgment, interpretation and decision.

◇Medical review of serious adverse events: Ensure tasks delegated to medical monitors are properly executed. Adhere to applicable regulations and ICH guidance regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to corporate policies and SOPs/WPDs.

◇Present standard medical processes to clients at business development meetings, investigator meetings, and communicate with various medical communities to explore and expand business.

◇Provide medical consultation to team members and help manage protocol related medical questions. Communicate clearly with project team members and clients, maintaining open communication to ensure all procedures are followed appropriately. Provide therapeutic training and protocol training on assigned studies, as requested.

◇Perform listing reviews as specified in the client contract and data validation manual, including review of coding listings and/or full safety listings as well as use of Patient Profiles and other tools to assess for potential safety signal. This position will be assigned to APAC components of global or regional studies. Including but not limited to global/regional studies with Japan component.

◇This person will also take care of a major responsibility of ICCC review, therapeutic area training to clinical team, supporting business development, and clients requests including F2F visits to investigators, KOLs and sites in Japan.

【その他情報】
契約期間：期間の定めなし
試用期間：3か月
■退職給付制度：有（確定拠出年金（日本型４０１K）制度）
■保険：社会保険（健康保険・厚生年金）、労働保険（雇用保険、労災保険）
■福利厚生：団体保険制度、慶弔見舞金、法人会員契約による全国会員制リゾート施設・スポーツクラブ等の利用制度（ベネフィット・ワン）、借り上げ社宅制度（会社指示の転勤の場合）
就業時間：9:00～18:00（標準的な勤務時間）
※本ポジションは管理監督者の為、非時間管理となります。
■休日：年間122日（土日祝日、年末年始5日間）
■有給休暇：試用期間終了後に10日～最大20日間付与
その他休暇：完全週休２日、夏季休暇、慶弔休暇、産前産後休業、育児休業、介護休業等
受動喫煙対策：あり　就業場所　全面禁煙
加入保険：雇用・労災・健康・厚生年金保険