お仕事情報

お仕事情報

Associate MD(在宅):SS-3488HY

  • 女性が活躍
  • 英語を活かす

業界大手のグローバルCROと日本の老舗CROとの合弁会社

求人コード SS-3488HY
募集職種 Associate MD(在宅)
職務内容 ■What to do:
Project Related Medical/Safety Support:
 Minimize potential risk to PPD 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 PPD’s corporate policies and SOPs/WPDs.
 Present PPD standard medical processes to clients at business development meetings, investigator meetings, and communicate with various medical communities to explore and expand PPD 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 PPD-SNBL, supporting business development in PPD-SNBL, and clients requests including F2F visits to investigators, KOLs and sites in Japan.
応募要件 対象年齢 Under 55
応募資格
■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 (preferred) or internal medicine related therapeutic area. -Be able to work both in an 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.
勤務地 東京をベースとした在宅勤務
年収 1000万円~1300万円
最終学歴 修士卒
推奨される資格要件 医師(MD)
その他 ■賃金形態:年俸制 (12分割) 
■通勤手当:会社規定に基づき支給
■賃金備考
 ・上記年収は目安です。経験、能力、前給を考慮し、ご相談の上決定
 ・別途、毎年3月末に業績に応じて業績賞与の支給があります。
■退職金:無
■福利厚生:社会保険完備(健康保険・雇用保険、労災保険、厚生年金)、通勤手当、確定拠出年金(日本型401K)制度、団体保険制度、各種慶弔見舞金、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
■所定労働時間:8時間、休憩60分
■フレックスタイム制 有 07:30-20:00の間で就業(コアタイム:11:00-16:00)
■休日:年間122日(土日祝日、夏季休暇3日間、年末年始5日間)
    その他(育児介護、慶弔産前産後)
■有給休暇:試用期間終了後に10日~最大20日間付与され、毎年有給付与日に新たに付与される。当年度分の繰り返しは次年度まで持ち越し可能。

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