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Medical Monitor

年収:1000万 ~ 1300万

ヘッドハンター案件

部署・役職名 Medical Monitor
職種
業種
勤務地
仕事内容 ■What to do:
Project Related Medical/Safety Support:
◇Minimize potential risk to X 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 guidances regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to X’s corporate policies and SOPs/WPDs.
◇Present X standard medical processes to clients at business development meetings, investigator meetings, and communicate with various medical communities to explore and expand X 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 in X, supporting business development in X, and clients requests including F2F visits to investigators, KOLs and sites in Japan.
労働条件 ■試用期間:3ヶ月間
■通勤手当:会社規定に基づき支給
■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:09:00-18:00
      ※フレックスタイム制を導入しております。
      ※フレキシブルタイム
       (始業) 7時30分から11時00分
       (終業) 16時00分から20時00分
       コアタイム 11時00分から16時00分
■所定労働時間:8時間、休憩60分(12:30~13:30)
■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:夏季休暇、慶弔休暇、産前産後休業、育児休業、介護休業等
応募資格

【必須(MUST)】

■Academic Qualification: -MD degree
■Required Knowledge and skill:
 - A certified license of a medical doctor.
 - Experience in hospital settings for at least 5 years, with a specialty of oncology, neuroscience, psychiatry, immunology, infectious disease physician are all very welcome.
 - Be able to work both in a Japan organization and a regional/global environment.
 - Experience in regulatory authority or pharma would be a plus, but not a must.
■Language: Both Japanese and English proficiency.

・医師免許は日本以外でも可。
・応募の際は、英語CV必須。
・在宅勤務を想定しているポジションですが、少なくとも月2回、最寄り(東京・大阪・鹿児島)のオフィスに出社できる方。
・上長とは英語でのコミュニケーション、他の社員とは日本語でのやり取りが基本となるため英語と日本語どちらもビジネスレベルの方。

面接は基本的にすべて英語面接です。
更新日 2020/10/16
求人番号 1504399

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